SleepNCT04679051
Long Sleep Duration and Vascular Function
A study testing Sleep duration in people with Sleep, run by Texas Tech University at 1 site in United States.
Trial summary
Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep duration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- recreationally active
- reporting no recent history of sleep problems
- not taking sleep-inducing medication
- not diabetic (fasting blood glucose <126 mg/dL)
Who cannot join
- show symptoms of insomnia
- smoke
- have a personal history of stroke or diabetes
- take birth control pills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulsatile Pressure and Long Sleep Duration on Cerebral Vascular Function
Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. The investigators hypothesize that long duration sleep has the ability to impair peripheral and cerebral vascular function in middle-aged to older adults.
Read the detailed description
The aim of this study is to compare the effect of long duration sleep (>9 hours) to recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive function, and peripheral vasodilatory function will be measured before and after each sleep protocol. A secondary objective of this study is to understand whether aerobic exercise can improve vascular function under conditions of different sleep durations. This information will shed light upon the impact of sleep parameters on exercise-induced improvements in vascular function.
- Conditions
- Sleep
- Being tested
- Sleep duration
- Keywords
- sleep duration, blood pressure, vasodilation, cognitive function
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep durationBehavioural
Participants will be asked to alter time in bed to achieve specified sleep durations.
| Study group | Role | What they receive |
|---|---|---|
| 8 hours time in bed | Experimental | Participants will be asked to spend 8 hours time in bed with the aim of achieving one week of normal sleep duration (7 to 8 hours). Receives: Behavioral: Sleep duration |
| 11 hours time in bed | Experimental | Participants will be asked to spend 11 hours time in bed with the aim of achieving one week of long duration sleep as defined as 9+ hours of sleep. Receives: Behavioral: Sleep duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed
Central aortic pulse pressure was measured one night during the week of 8 hours in bed, then again one night during the week of 11 hours in bed. Blood pressure was measured using an Oscar2 ambulatory blood pressure device. The device started recordings one hour prior to sleep and was programmed to take measurements once every 30 minutes during sleep until 10:00pm then every 45 minutes after 10:00pm until participants arose from bed. The change in central aortic pulse pressure from being awake to being asleep was compared between 8 and 11 hours in bed conditions.
Measured: One night during each time in bed condition
Change in Cerebral Vascular Reactivity After 11 Hours in Bed
Blood flow measured in the middle cerebral artery during hypercapnia was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Cerebral blood flow was measured using transcranial Doppler during 3 minutes of transient hypercapnia induced by rebreathing. Cerebral vascular reactivity was considered as the percent increase in cerebral blood flow at the end of 3 minutes of rebreathing relative to the Torr change in end-tidal carbon dioxide (percent change/Torr).
Measured: Morning after one week of 8 and 11 hours in bed
Change in Peak Reactive Hyperemia After 11 Hours in Bed
Peak forearm blood flow was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Peak reactive hyperemia in the forearm (ml/100ml/min) was measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow was considered the highest blood flow measurement after the blood pressure cuff was deflated.
Measured: Morning after one week of 8 and 11 hours in bed
Change in Arterial Stiffness After 11 Hours in Bed
Arterial stiffness was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Carotid-femoral pulse wave velocity was used as the measure of arterial stiffness. Radial arterial tonometry was used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave was then used to calculate pulse wave velocity from transit time and carotid-femoral path length.
Measured: Morning after one week of 8 and 11 hours in bed
Secondary outcomes (3)
Change in Spatial Orientation After Aerobic Exercise
Score from a Manikin test of spatial orientation that participants took using a computer with automated software (Automated Neuropsychological Assessment Metrics, known as ANAM). Scores reflect "throughput scores" which is a continuous variable that is the ratio of correct answers per minute during the Manikin test. Higher throughput scores mean better outcome, in this case, better spatial orientation ability. Participants took the Manikin test after one week of 8 and 11 hours in bed (i.e., baseline) then the morning after one day of aerobic exercise. Exercise consisted of three sessions of 10 minutes brisk walking at a heart rate considered to be moderate intensity (50-70% of age-predicted maximal heart rate). Results reported reflect the change in throughput scores after exercise (morning after exercise minus baseline).
Measured: Baseline and after exercise
Change in Executive Function After Aerobic Exercise
Executive function was assessed using a Stroop color-word test that participants took using a computer with automated software (Automated Neuropsychological Assessment Metrics, known as ANAM). Score reported are number of correct answers. A higher score means a better outcome, in this case, better executive functioning. Participants took the Stoop color-word test after one week of 8 and 11 hours in bed (i.e., baseline) then the morning after one day of aerobic exercise. Exercise consisted of three sessions of 10 minutes brisk walking at a heart rate considered to be moderate intensity (50-70% of age-predicted maximal heart rate). Results reported reflect the change in score after exercise (morning after exercise minus baseline).
Measured: Baseline and after exercise
Change in Mental Flexibility After Aerobic Exercise
Mental flexibility was assessed using a Switching task that participants took on a computer with automated software (Automated Neuropsychological Assessment Metrics, known as ANAM). Scores reflect "throughput scores" which is a continuous variable that is the ratio of correct answers per minute during the Manikin test. Higher throughput scores mean better outcome, in this case, better mental flexibility. Participants took the Switching task after one week of 8 and 11 hours in bed (i.e., baseline) then the morning after one day of aerobic exercise. Exercise consisted of three sessions of 10 minutes brisk walking at a heart rate considered to be moderate intensity (50-70% of age-predicted maximal heart rate). Results reported reflect the change in throughput scores after exercise (morning after exercise minus baseline).
Measured: Baseline and after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start16 Oct 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Joaquin U Gonzales, PhD, Texas Tech University
- Investigators
- Joaquin U Gonzales, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679051
- Sponsor's protocol ID
- 19IPLOI34760579
- Status last verified
- Jan 2023
- First submitted
- 11 Dec 2020
- Last updated
- 13 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsatile Pressure and Long Sleep Duration on Cerebral Vascular Function
- ClinicalTrials.gov ID
- NCT04679051
- Acronym / sponsor ID
- 19IPLOI34760579
- Conditions
- Sleep
- Keywords
- sleep duration, blood pressure, vasodilation, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Posted 12 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. The investigators hypothesize that long duration sleep has the ability to impair peripheral and cerebral vascular function in middle-aged to older adults.
Detailed description
The aim of this study is to compare the effect of long duration sleep (>9 hours) to recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive function, and peripheral vasodilatory function will be measured before and after each sleep protocol. A secondary objective of this study is to understand whether aerobic exercise can improve vascular function under conditions of different sleep durations. This information will shed light upon the impact of sleep parameters on exercise-induced improvements in vascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.
| Arm | Type | Receives |
|---|---|---|
| 8 hours time in bed | Experimental | Behavioral: Sleep durationParticipants will be asked to spend 8 hours time in bed with the aim of achieving one week of normal sleep duration (7 to 8 hours). |
| 11 hours time in bed | Experimental | Behavioral: Sleep durationParticipants will be asked to spend 11 hours time in bed with the aim of achieving one week of long duration sleep as defined as 9+ hours of sleep. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- recreationally active
- reporting no recent history of sleep problems
- not taking sleep-inducing medication
- not diabetic (fasting blood glucose <126 mg/dL)
Key exclusion criteria (4 listed)
- show symptoms of insomnia
- smoke
- have a personal history of stroke or diabetes
- take birth control pills
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 |
|---|---|---|
| Sleep durationParticipants will be asked to alter time in bed to achieve specified sleep durations. | Behavioural | 11 hours time in bed, 8 hours time in bed |
Primary outcome
Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed
Time frame: One night during each time in bed condition
Central aortic pulse pressure was measured one night during the week of 8 hours in bed, then again one night during the week of 11 hours in bed. Blood pressure was measured using an Oscar2 ambulatory blood pressure device. The device started recordings one hour prior to sleep and was programmed to take measurements once every 30 minutes during sleep until 10:00pm then every 45 minutes after 10:00pm until participants arose from bed. The change in central aortic pulse pressure from being awake to being asleep was compared between 8 and 11 hours in bed conditions.
Change in Cerebral Vascular Reactivity After 11 Hours in Bed
Time frame: Morning after one week of 8 and 11 hours in bed
Blood flow measured in the middle cerebral artery during hypercapnia was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Cerebral blood flow was measured using transcranial Doppler during 3 minutes of transient hypercapnia induced by rebreathing. Cerebral vascular reactivity was considered as the percent increase in cerebral blood flow at the end of 3 minutes of rebreathing relative to the Torr change in end-tidal carbon dioxide (percent change/Torr).
Change in Peak Reactive Hyperemia After 11 Hours in Bed
Time frame: Morning after one week of 8 and 11 hours in bed
Peak forearm blood flow was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Peak reactive hyperemia in the forearm (ml/100ml/min) was measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow was considered the highest blood flow measurement after the blood pressure cuff was deflated.
Change in Arterial Stiffness After 11 Hours in Bed
Time frame: Morning after one week of 8 and 11 hours in bed
Arterial stiffness was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Carotid-femoral pulse wave velocity was used as the measure of arterial stiffness. Radial arterial tonometry was used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave was then used to calculate pulse wave velocity from transit time and carotid-femoral path length.
3 secondary outcomes
Change in Spatial Orientation After Aerobic Exercise
Time frame: Baseline and after exercise
Change in Executive Function After Aerobic Exercise
Time frame: Baseline and after exercise
Change in Mental Flexibility After Aerobic Exercise
Time frame: Baseline and after exercise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date
Related trials for Sleep
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
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.
Joaquin U Gonzales, PhD principal investigator
Texas Tech 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 Sleep duration in people with Sleep, run by Texas Tech 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?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 13 Jan 2023. 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. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed (time frame: One night during each time in bed condition). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2023.