Obstructive Sleep ApneaNCT02202811
Circadian Rhythms and Cardiovascular Risk
A study testing Forced Desynchrony in people with Obstructive Sleep Apnea, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Forced Desynchrony
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- BMI less than 40
- Moderate to severe OSA (AHI)>15
- No current or previous pharmacological treatment for hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure.
People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian phase in some of the same key indices of CV risk. The investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Forced Desynchrony
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced DesynchronyBehavioural
all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Experimental | Forced Desynchrony, OSA Receives: Behavioral: Forced Desynchrony |
| Control | Placebo comparator | Forced Desynchrony, Control Receives: Behavioral: Forced Desynchrony |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of systolic and diastolic BP during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of blood pressure (BP)
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of systolic and diastolic BP during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma cortisol concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma cortisol concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of heart rate
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of heart rate during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of heart rate
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of heart rate during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of cardiac vagal tone during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of cardiac vagal tone during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary outcomes (30)
Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma tPA concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma tPA concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of vascular endothelial function during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of vascular endothelial function
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of vascular endothelial function during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma PAI-1 concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma PAI-1 concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma MDA concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma MDA concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma 8-isoprostane concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma 8-isoprostane concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Measured: Over 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startAug 2014
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurabh Thosar, Oregon Health and Science University
- Investigators
- Steven A Shea, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202811
- Sponsor's protocol ID
- OSA 00010101
- Status last verified
- Jun 2025
- First submitted
- 17 Jul 2014
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Thosar SS, Bowles NP, Butler MP, McHill AW, Rice SPM, Emens JS, Shea SA. Endogenous Circadian System Attenuates Nighttime Vascular Endothelial Function in People With Untreated Obstructive Sleep Apnea. J Am Heart Assoc. 2025 Nov 18;14(22):e043596. doi: 10.1161/JAHA.125.043596. Epub 2025 Nov 6.
PubMed 41195783Thosar SS, Berman AM, Herzig MX, McHill AW, Bowles NP, Swanson CM, Clemons NA, Butler MP, Clemons AA, Emens JS, Shea SA. Circadian Rhythm of Vascular Function in Midlife Adults. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1203-1211. doi: 10.1161/ATVBAHA.119.312682.
PubMed 31070470
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythms and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT02202811
- Acronym / sponsor ID
- OSA 00010101
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure.
People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian phase in some of the same key indices of CV risk. The investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in OSA.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | Experimental | Behavioral: Forced DesynchronyForced Desynchrony, OSA |
| Control | Placebo comparator | Behavioral: Forced DesynchronyForced Desynchrony, Control |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced Desynchronyall sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock. | Behavioural | Control, Obstructive Sleep Apnea |
Primary outcome
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of systolic and diastolic BP during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of blood pressure (BP)
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of systolic and diastolic BP during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma cortisol concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma cortisol concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of heart rate
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of heart rate during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of heart rate
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of heart rate during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of cardiac vagal tone during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of cardiac vagal tone during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture
Time frame: Over 5 days
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
30 secondary outcomes
Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of vascular endothelial function
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture
Time frame: Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture
Time frame: Over 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 41195783Thosar SS, Bowles NP, Butler MP, McHill AW, Rice SPM, Emens JS, Shea SA. Endogenous Circadian System Attenuates Nighttime Vascular Endothelial Function in People With Untreated Obstructive Sleep Apnea. J Am Heart Assoc. 2025 Nov 18;14(22):e043596. doi: 10.1161/JAHA.125.043596. Epub 2025 Nov 6.
- Derived from this study: PubMed 31070470Thosar SS, Berman AM, Herzig MX, McHill AW, Bowles NP, Swanson CM, Clemons NA, Butler MP, Clemons AA, Emens JS, Shea SA. Circadian Rhythm of Vascular Function in Midlife Adults. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1203-1211. doi: 10.1161/ATVBAHA.119.312682.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Shea, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced Desynchrony in people with Obstructive Sleep Apnea, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration (time frame: Over 5 days). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.