Obstructive Sleep ApneaNCT00177892
Obstructive Sleep Apnea (OSA) and Metabolic Syndrome: Role of Oxidative Stress
A study testing sleep disruption and sleep with and without positive pressure in people with Obstructive Sleep Apnea and Metabolic Syndrome X, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to define the mechanism(s) through which Obstructive Sleep Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Metabolic Syndrome X
- What is being tested?
- sleep disruption and sleep with and without positive pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2008
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoker for at least 6 months
- No history of movement disorder during sleep, or circadian rhythm disorder
- No excessive daytime sleepiness
- No history of chronic insomnia, mood or affective disorders or other psychiatric disorders
- Participants maintain a regular sleep-wake pattern with an estimated sleep time between 6.5 and 10 hours per night
- Ability and willingness to avoid meat with its juice (gravy), cured or smoked foods and green leafy vegetables, fruit and fruit juices, food products or vitamin supplements containing vitamin C and E supplements for at least 1 day prior to and during the study periods
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- Consumption of less than 1 alcoholic beverage per day
- Ability to understand the study and sign the informed consent
- Not currently pregnant
- Live within 45 miles of the study site
- No uncontrolled hypertension (blood pressure greater than 150/100)
- Willingness to avoid caffeinated beverages and food during the study protocol period
- Participants With Sleep Apnea:
- Diagnosis of severe Obstructive Sleep Apnea and Hypopnea (OSAH) (RDI greater than 25) and initiation of positive airway pressure therapy more than 1 month before enrollment
- Must have had an adequate clinical titration of positive airway pressure therapy
- On positive airway pressure for at least 1 month with adherence of more than 5 hours of use per day with no history of snoring, no excessive daytime sleepiness and no reported observed apnea episodes on positive airway pressure
- Willing to sleep with and without positive airway pressure therapy as required by the study protocol
Who cannot join
- History or physical examination evidence of active coronary artery disease, heart failure, cardiomyopathy, syncope, potentially life-threatening arrhythmia, stroke, transient ischemic attack, neurologic impairment, renal, hepatic or thyroid disease (unless on stable thyroid replacement medication); history of diabetes mellitus; history of cancer within the past 10 years (other than basal cell carcinoma), venous thrombosis, or collagen-vascular disease or other condition that the investigators believe may be exacerbated by participation in the stud
- History of awakening with angina pectoris
- Currently taking medication for mood or affective disorders or that affect heme metabolism, autonomic nervous system or sleep architecture, or prescribed nitrates or corticosteroids
- Physician-diagnosed Alzheimer's or non-Alzheimer's dementia
- Previous surgery for sleep apnea
- Hematocrit less than 32
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- Use of a hearing aid in one or both ears
- History of a bleeding disorder, abnormal bleeding, or known adverse reaction to heparin
- Inability to obtain venous blood or a low likelihood of obtaining venous access as required in this protocol
- History of migraine of a nature, frequency, and severity that, in the investigators' judgement, may be precipitated by participation in the protocol
- Presence of a potentially life-threatening dysrhythmia on the clinical diagnostic PSG
- History of motor vehicle accident due to falling asleep; not currently employed as a driver in the transportation industry or an airplane pilot
- Lipid-lowering agents for participants without a history of sleep apnea
- Individuals on positive airway pressure therapy for sleep apnea must not have lost more than 10 pounds of weight since starting this treatment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15261
Marcie Conrad, BS, 412-383-1628, conradm@dom.pitt.edu
Jason Rosol, 412-383-1593, rosolj@dom.pitt.edu
About this study
Official title: OSA and Metabolic Syndrome: Role of Oxidative Stress
The purpose of this study is to define the mechanism(s) through which Obstructive Sleep Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes which are consistent with the metabolic syndrome.
Read the detailed description
The metabolic syndrome has been defined as insulin resistance, central obesity, systemic hypertension and dyslipidemia and is associated with increased cardiovascular (CV) risk. Obstructive Sleep Apnea-Hypopnea (OSAH) is also associated with increased CV risk and insulin resistance. Since OSAH is associated with oxidative stress and pro-inflammatory processes, both of which are associated with insulin resistance, it follows that oxidative stress and inflammation may mediate the linkage between OSAH, insulin resistance and ultimately, the metabolic syndrome.
The overall goal of this research is to test the hypothesis that oxidative stress and inflammation link OSAH to insulin resistance as well as other CV risk-promoting conditions reflecting the metabolic syndrome (e.g. hyperlipidemia). We will specifically test if the individual sleep consequences of OSAH, including sleep fragmentation and intermittent sleep hypoxia, promote oxidative stress and inflammation which in turn promote insulin resistance and other features of the metabolic syndrome.
Aim 1a: To determine the effect of sleep fragmentation on oxidative stress and inflammation and features of the metabolic syndrome including insulin resistance, dyslipidemia, obesity, and hypertension.
Aim 1b: To assess the interaction between pre-existing metabolic syndrome and the overweight condition without metabolic syndrome, with regard to the effects of sleep fragmentation on the study variables, we will contrast the effect of experimentally-induced sleep fragmentation in non-OSAH/overweight individuals with the metabolic syndrome, non-OSAH/overweight individuals without metabolic syndrome and a control group of non-OSAH/normal weight without metabolic syndrome.
Aim: 2: To evaluate the effect of intermittent sleep hypoxia on oxidative stress and inflammation and explore the relationships between these two processes and insulin resistance, lipid profile, heart period variability and plasma cortisol.
Aim: 3: Using microarray data from peripheral monocytes, we will explore if specific gene expression patterns after the study conditions are associated with alterations consistent with metabolic syndrome.
Aim: 4: This exploratory aim is to collect preliminary data regarding the correlation among genetic variations (polymorphisms), gene expression patterns (microarray) and resultant protein production (proteomics). These data will be used for hypothesis development.
- Conditions
- Obstructive Sleep Apnea, Metabolic Syndrome X
- Being tested
- sleep disruption, sleep with and without positive pressure
- Keywords
- Sleep fragmentation, Intermittent hypoxia, Obstructive Sleep Apnea, Metabolic Syndrome, Insulin resistance
- Medical subject headings
- Sleep Apnea, Obstructive, Metabolic Syndrome, Sleep Deprivation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep disruptionProcedure or surgery
experimentally-induced Sleep Fragmentation
sleep with and without positive pressureProcedure or surgery
Also called fragmentation + normoxia, fragmentation + hypoxia
OSAH patients with and without chronic positive airway pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | non-OSAH/overweight individuals with the Metabolic Syndrome Receives: Procedure: sleep disruption |
| 2 | Experimental | non-OSAH/overweight individuals without Metabolic Syndrome Receives: Procedure: sleep disruption |
| 3 | Active comparator | non-OSAH/normal weight without Metabolic Syndrome Receives: Procedure: sleep disruption |
| 4 | Experimental | OSAH patients with chronic positive airway pressure therapy Receives: Procedure: sleep with and without positive pressure |
| 5 | Experimental | OSAH patients without chronic positive airway pressure therapy Receives: Procedure: sleep with and without positive pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating and exhaled biomarkers of oxidative stress and pro-inflammatory cytokines, insulin resistance, lipid profile, plasma cortisol, and heart period variability (a reflection of sympathovagal tone)
Measured: before and after 2 consecutive nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Pittsburgh
- Investigators
- Mark H Sanders, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177892
- Sponsor's protocol ID
- AG0089
- Other IDs
- 5R01AG023977
- Status last verified
- Feb 2008
- First submitted
- 13 Sep 2005
- Last updated
- 3 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSA and Metabolic Syndrome: Role of Oxidative Stress
- ClinicalTrials.gov ID
- NCT00177892
- Acronym / sponsor ID
- AG0089
- Conditions
- Obstructive Sleep Apnea, Metabolic Syndrome X
- Keywords
- Sleep fragmentation, Intermittent hypoxia, Obstructive Sleep Apnea, Metabolic Syndrome, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- University of Pittsburgh
- Study start
- Sep 2003
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 15 Sep 2005 (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 define the mechanism(s) through which Obstructive Sleep Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes which are consistent with the metabolic syndrome.
Detailed description
The metabolic syndrome has been defined as insulin resistance, central obesity, systemic hypertension and dyslipidemia and is associated with increased cardiovascular (CV) risk. Obstructive Sleep Apnea-Hypopnea (OSAH) is also associated with increased CV risk and insulin resistance. Since OSAH is associated with oxidative stress and pro-inflammatory processes, both of which are associated with insulin resistance, it follows that oxidative stress and inflammation may mediate the linkage between OSAH, insulin resistance and ultimately, the metabolic syndrome.
The overall goal of this research is to test the hypothesis that oxidative stress and inflammation link OSAH to insulin resistance as well as other CV risk-promoting conditions reflecting the metabolic syndrome (e.g. hyperlipidemia). We will specifically test if the individual sleep consequences of OSAH, including sleep fragmentation and intermittent sleep hypoxia, promote oxidative stress and inflammation which in turn promote insulin resistance and other features of the metabolic syndrome.
Aim 1a: To determine the effect of sleep fragmentation on oxidative stress and inflammation and features of the metabolic syndrome including insulin resistance, dyslipidemia, obesity, and hypertension.
Aim 1b: To assess the interaction between pre-existing metabolic syndrome and the overweight condition without metabolic syndrome, with regard to the effects of sleep fragmentation on the study variables, we will contrast the effect of experimentally-induced sleep fragmentation in non-OSAH/overweight individuals with the metabolic syndrome, non-OSAH/overweight individuals without metabolic syndrome and a control group of non-OSAH/normal weight without metabolic syndrome.
Aim: 2: To evaluate the effect of intermittent sleep hypoxia on oxidative stress and inflammation and explore the relationships between these two processes and insulin resistance, lipid profile, heart period variability and plasma cortisol.
Aim: 3: Using microarray data from peripheral monocytes, we will explore if specific gene expression patterns after the study conditions are associated with alterations consistent with metabolic syndrome.
Aim: 4: This exploratory aim is to collect preliminary data regarding the correlation among genetic variations (polymorphisms), gene expression patterns (microarray) and resultant protein production (proteomics). These data will be used for hypothesis development.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: sleep disruptionnon-OSAH/overweight individuals with the Metabolic Syndrome |
| 2 | Experimental | Procedure: sleep disruptionnon-OSAH/overweight individuals without Metabolic Syndrome |
| 3 | Active comparator | Procedure: sleep disruptionnon-OSAH/normal weight without Metabolic Syndrome |
| 4 | Experimental | Procedure: sleep with and without positive pressureOSAH patients with chronic positive airway pressure therapy |
| 5 | Experimental | Procedure: sleep with and without positive pressureOSAH patients without chronic positive airway pressure therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Nonsmoker for at least 6 months
- No history of movement disorder during sleep, or circadian rhythm disorder
- No excessive daytime sleepiness
- No history of chronic insomnia, mood or affective disorders or other psychiatric disorders
- Participants maintain a regular sleep-wake pattern with an estimated sleep time between 6.5 and 10 hours per night
Key exclusion criteria (14 listed)
- History or physical examination evidence of active coronary artery disease, heart failure, cardiomyopathy, syncope, potentially life-threatening arrhythmia, stroke, transient ischemic attack, neurologic impairment, renal, hepatic or thyroid disease (unless on stable thyroid replacement medication); history of diabetes mellitus; history of cancer within the past 10 years (other than basal cell carcinoma), venous thrombosis, or collagen-vascular disease or other condition that the investigators believe may be exacerbated by participation in the stud
- History of awakening with angina pectoris
- Currently taking medication for mood or affective disorders or that affect heme metabolism, autonomic nervous system or sleep architecture, or prescribed nitrates or corticosteroids
- Physician-diagnosed Alzheimer's or non-Alzheimer's dementia
- Previous surgery for sleep apnea
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 disruptionexperimentally-induced Sleep Fragmentation | Procedure or surgery | 1, 2, 3 |
| sleep with and without positive pressureAlso: fragmentation + normoxia, fragmentation + hypoxiaOSAH patients with and without chronic positive airway pressure therapy | Procedure or surgery | 4, 5 |
Primary outcome
circulating and exhaled biomarkers of oxidative stress and pro-inflammatory cytokines, insulin resistance, lipid profile, plasma cortisol, and heart period variability (a reflection of sympathovagal tone)
Time frame: before and after 2 consecutive nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2008.
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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.
Mark H Sanders, MD principal investigator
University of Pittsburgh
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 disruption and sleep with and without positive pressure in people with Obstructive Sleep Apnea and Metabolic Syndrome X, run by National Institute on Aging (NIA) 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 17 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Mar 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynnette Robinson, BS (412-647-1345, robinsonlm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating and exhaled biomarkers of oxidative stress and pro-inflammatory cytokines, insulin resistance, lipid profile, plasma cortisol, and heart period variability (a reflection of sympathovagal tone) (time frame: before and after 2 consecutive nights). 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 3 Mar 2008.