Sleep Apnea SyndromesNCT00371293
The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
A study testing Weight Loss Program and CPAP therapy in people with Sleep Apnea Syndromes and Inflammation, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes, Inflammation
- What is being tested?
- Weight Loss Program and CPAP therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Dec 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe OSA (as defined by an apnea-hypopnea index [AHI] score greater than 15 events per hour)
- Body mass index greater than 30 kg/m
- Baseline CRP greater than 1.0 mg/dL
Who cannot join
- Predominant central sleep apnea
- Type 1 Diabetes
- Type 2 Diabetes associated with either: (a) unstable anti-diabetic therapy (anti-diabetic medication changes within past 3 months); (b) Hemoglobin A1C levels > 7%; (c) Inability to perform home blood glucose monitoring (fingerstick checks).
- Requires use of supplemental oxygen
- Acute coronary syndrome or stroke in the 3 months prior to study entry
- A high-risk occupation or motor vehicle driving record, as defined by a score of 10 points or higher on an occupational and driving habits questionnaire
Show all 20Show fewer
- Blood pressure greater than 160/95 mm Hg (may be re-screened after blood pressure control is obtained)
- Active infection, cancer, or chronic inflammatory disorder
- Use of systemic steroids
- Currently on an unstable dose of statin therapy (participants taking statins must be on a stable dose for at least 8 weeks prior to study entry)
- Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
- Consumes more than 14 alcoholic drinks per week
- History of surgery in the 3 months prior to study entry
- Sustained ventricular or supraventricular tachycardia greater than 30 seconds during overnight sleep study
- Known left ventricular ejection fraction less than 30% or decompensated congestive heart failure requiring hospitalization in the year prior to study entry
- Any episode of decompensated respiratory function requiring hospitalization in the year prior to study entry
- Severe restless leg syndrome or chronic pain syndrome that gives rise to frequent awakenings at night, as determined during the overnight sleep study (individuals may still be enrolled if these sleep-disrupting disorders can be resolved prior to study entry)
- Pregnant or likely to become pregnant (i.e., pre-menopausal and not using a form of birth control)
- Severe depression, as defined by a score of 29 or higher on the Beck Depression Index, or suicidal ideation
- Serious medical or psychological condition that may compromise the participant's safety or successful participation in the study, in the opinion of the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19014
University of Pennsylvania
Philadelphia, Pennsylvania, 19014
About this study
Official title: Inflammatory Response to Sleep Apnea in Obese Subjects: The Cardiovascular Effects of Obstructive Sleep Apnea (COSA) Study
Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. This study will evaluate whether OSA or obesity plays the primary role in inflammation related to heart disease. The study will also determine the independent effects of OSA and obesity on insulin resistance and blood vessel function.
Read the detailed description
OSA is a common sleep disorder that is characterized by a brief collapse of the upper airway during sleep. This blockage prevents air from flowing properly into the lungs and causes pauses in breathing. If left untreated, OSA can cause high blood pressure, memory problems, weight gain, impotency, and headaches. It is also associated with an increased risk of inflammation-related heart conditions. Obesity is common among individuals with OSA and it may also be associated with inflammation. It is not known, however, whether the increased risk of heart problems is caused primarily by the inflammatory effects of OSA or obesity.
The most common treatment for OSA is continuous positive airway pressure (CPAP) therapy, in which a mask is worn over the nose during sleep. Air flows through the mask to maintain a level of pressure that keeps the throat open. The most common treatment for obesity is weight loss. This study will determine the primary cause of heart-related inflammation by evaluating the individual and combined effects of CPAP therapy and a weight loss program in treating obese individuals with OSA. The study will also determine the independent effects of these therapies on insulin resistance and blood vessel function (arterial stiffness, central arterial pressures).
This study will enroll obese individuals with moderate to severe OSA for a total of 24 weeks. Potential participants will first take part in an overnight sleep study at the University of Pennsylvania sleep lab. Sensors will monitor body functions during the night, including brain and muscle activity, eye movement, heart rate, breathing effort, air flow, and blood oxygen levels. Eligible participants will then be randomly assigned to CPAP therapy, a weight loss program, or a combination of the two. Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. Participants receiving CPAP therapy will use a CPAP machine each night while they sleep. Study visits for all participants will occur at baseline and Weeks 6, 12, and 24. Blood will be collected to measure levels of triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and levels of C-reactive protein (CRP), which is an inflammation biomarker. Insulin resistance will be evaluated using a glucose tolerance test, and blood vessel function will be evaluated using a brachial artery reactivity test in which artery size and blood flow will be measured with an ultrasound.
- Conditions
- Sleep Apnea Syndromes, Inflammation
- Being tested
- Weight Loss Program, CPAP therapy
- Keywords
- Sleep Apnea, C-Reactive Protein, Obesity, Insulin Resistance, Arterial stiffness
- Medical subject headings
- Sleep Apnea Syndromes, Inflammation, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss ProgramBehavioural
Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapyDevice
Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive CPAP therapy. Receives: Device: CPAP therapy |
| 2 | Active comparator | Participants will take part in a weight loss program. Receives: Behavioral: Weight Loss Program |
| 3 | Experimental | Participants will receive CPAP therapy and take part in a weight loss program. Receives: Behavioral: Weight Loss Program; Device: CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Measured: Measured at Baseline and Week 24
Secondary outcomes (4)
Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)
Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman's minimal model.
Measured: Measured at Baseline and Week 24
Change in LDL Cholesterol Levels
Measured: Measured at Baseline and Week 24
Change in Triglyceride Levels
Measured: Measured at Baseline and Week 24
Change in HDL Cholesterol Levels
Measured: Measured at Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2012
- Study completionDec 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Julio A. Chirinos, University of Pennsylvania
- Investigators
- Julio A. Chirinos, MD, Principal investigator, University of Pennsylvania, Philadelphia Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371293
- Sponsor's protocol ID
- 442
- Other IDs
- R01HL080076-01A1
- Status last verified
- Feb 2017
- First submitted
- 1 Sep 2006
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jain S, Gurubhagavatula I, Townsend R, Kuna ST, Teff K, Wadden TA, Chittams J, Hanlon AL, Maislin G, Saif H, Broderick P, Ahmad Z, Pack AI, Chirinos JA. Effect of CPAP, Weight Loss, or CPAP Plus Weight Loss on Central Hemodynamics and Arterial Stiffness. Hypertension. 2017 Dec;70(6):1283-1290. doi: 10.1161/HYPERTENSIONAHA.117.09392. Epub 2017 Oct 16.
PubMed 29038203Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.
PubMed 24918371
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response to Sleep Apnea in Obese Subjects: The Cardiovascular Effects of Obstructive Sleep Apnea (COSA) Study
- ClinicalTrials.gov ID
- NCT00371293
- Acronym / sponsor ID
- 442
- Conditions
- Sleep Apnea Syndromes, Inflammation
- Keywords
- Sleep Apnea, C-Reactive Protein, Obesity, Insulin Resistance, Arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. This study will evaluate whether OSA or obesity plays the primary role in inflammation related to heart disease. The study will also determine the independent effects of OSA and obesity on insulin resistance and blood vessel function.
Detailed description
OSA is a common sleep disorder that is characterized by a brief collapse of the upper airway during sleep. This blockage prevents air from flowing properly into the lungs and causes pauses in breathing. If left untreated, OSA can cause high blood pressure, memory problems, weight gain, impotency, and headaches. It is also associated with an increased risk of inflammation-related heart conditions. Obesity is common among individuals with OSA and it may also be associated with inflammation. It is not known, however, whether the increased risk of heart problems is caused primarily by the inflammatory effects of OSA or obesity.
The most common treatment for OSA is continuous positive airway pressure (CPAP) therapy, in which a mask is worn over the nose during sleep. Air flows through the mask to maintain a level of pressure that keeps the throat open. The most common treatment for obesity is weight loss. This study will determine the primary cause of heart-related inflammation by evaluating the individual and combined effects of CPAP therapy and a weight loss program in treating obese individuals with OSA. The study will also determine the independent effects of these therapies on insulin resistance and blood vessel function (arterial stiffness, central arterial pressures).
This study will enroll obese individuals with moderate to severe OSA for a total of 24 weeks. Potential participants will first take part in an overnight sleep study at the University of Pennsylvania sleep lab. Sensors will monitor body functions during the night, including brain and muscle activity, eye movement, heart rate, breathing effort, air flow, and blood oxygen levels. Eligible participants will then be randomly assigned to CPAP therapy, a weight loss program, or a combination of the two. Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. Participants receiving CPAP therapy will use a CPAP machine each night while they sleep. Study visits for all participants will occur at baseline and Weeks 6, 12, and 24. Blood will be collected to measure levels of triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and levels of C-reactive protein (CRP), which is an inflammation biomarker. Insulin resistance will be evaluated using a glucose tolerance test, and blood vessel function will be evaluated using a brachial artery reactivity test in which artery size and blood flow will be measured with an ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: CPAP therapyParticipants will receive CPAP therapy. |
| 2 | Active comparator | Behavioral: Weight Loss ProgramParticipants will take part in a weight loss program. |
| 3 | Experimental | Behavioral: Weight Loss Program, Device: CPAP therapyParticipants will receive CPAP therapy and take part in a weight loss program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe OSA (as defined by an apnea-hypopnea index [AHI] score greater than 15 events per hour)
- Body mass index greater than 30 kg/m
- Baseline CRP greater than 1.0 mg/dL
Key exclusion criteria (20 listed)
- Predominant central sleep apnea
- Type 1 Diabetes
- Type 2 Diabetes associated with either: (a) unstable anti-diabetic therapy (anti-diabetic medication changes within past 3 months); (b) Hemoglobin A1C levels > 7%; (c) Inability to perform home blood glucose monitoring (fingerstick checks).
- Requires use of supplemental oxygen
- Acute coronary syndrome or stroke in the 3 months prior to study entry
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 |
|---|---|---|
| Weight Loss ProgramParticipants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. | Behavioural | 2, 3 |
| CPAP therapyParticipants receiving CPAP therapy will use a CPAP machine each night while they sleep. | Device | 1, 3 |
Primary outcome
Inflammation
Time frame: Measured at Baseline and Week 24
4 secondary outcomes
Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)
Time frame: Measured at Baseline and Week 24
Change in LDL Cholesterol Levels
Time frame: Measured at Baseline and Week 24
Change in Triglyceride Levels
Time frame: Measured at Baseline and Week 24
Change in HDL Cholesterol Levels
Time frame: Measured at Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29038203Jain S, Gurubhagavatula I, Townsend R, Kuna ST, Teff K, Wadden TA, Chittams J, Hanlon AL, Maislin G, Saif H, Broderick P, Ahmad Z, Pack AI, Chirinos JA. Effect of CPAP, Weight Loss, or CPAP Plus Weight Loss on Central Hemodynamics and Arterial Stiffness. Hypertension. 2017 Dec;70(6):1283-1290. doi: 10.1161/HYPERTENSIONAHA.117.09392. Epub 2017 Oct 16.
- Derived from this study: PubMed 24918371Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.
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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.
Julio A. Chirinos, MD principal investigator
University of Pennsylvania, Philadelphia Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Program and CPAP therapy in people with Sleep Apnea Syndromes and Inflammation, run by University of Pennsylvania at 2 sites 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 3 inclusion and 20 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 5 Apr 2017). 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?
Inflammation (time frame: Measured at Baseline and Week 24). 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 NCT00371293, 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 5 Apr 2017.