Status:
COMPLETED
Sleep Apnea Intervention for Cardiovascular Disease Reduction
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this probl...
Detailed Description
In this pilot randomized controlled trial, we will assess the effectiveness of CPAP therapy to reduce the burden of cardiovascular disease (CVD) and CVD risk factors in patients with moderate to sever...
Eligibility Criteria
Inclusion
- Obstructive apnea hypopnea index (AHI) ≥ 15
- Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)
- Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention.
- Established CVD,or having diabetes mellitus, defined by one or more of the following:
- Prior myocardial infarction
- Coronary artery revascularization procedure (≥4 months before study entry)
- Angiographically documented stenosis (\>70%) of a major coronary artery
- Prior ischemic stroke without major functional impairment
- Diabetes mellitus treated with medication or ≥ 2 fasting glucose levels ≥ 126 mg/dl
- OR
- Three or more of the following established CVD risk factors:
- Hypertension treated with medications or systolic BP \> 140 or diastolic BP \> 90 on ≥ 2 occasions
- Male sex
- BMI ≥ 30
- Total cholesterol \> 240 mg/dl or LDL cholesterol \> 160 mg/dl or HDL \< 45 mg/dl
- \> 10 pack years of smoking
Exclusion
- Diagnosed heart failure with known cardiac ejection fraction of \< 35% or New York Heart Association (NYHA) class 3 or 4 status
- Less than 4 months since myocardial infarction (MI), stroke or revascularization procedure
- Poorly controlled hypertension (\>170/\>100)
- Prior stroke with functional impairment interfering with ability to complete the protocol
- Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. oral steroids; chronic opioid use; self- reported chronic kidney disease or, if measured, creatinine \> 2.5 mg/dl or glomerular filtration rate (GFR) \< 30; anemia with Hgb \< 10, etc.)
- Resting oxygen saturation \< 90% or nocturnal oxygen saturation \<85% for \> 10% of the sleep period;
- Use of prescribed PAP for sleep apnea within the prior 2 years
- Report of inability to spend \>6 hrs in bed
- Any use of prescribed PAP for sleep apnea
- Severe sleepiness defined by an Epworth Sleepiness Score of \>14 or report of falling asleep driving in the prior 2 years
- Working as a professional driver
- Low risk related to having sleep apnea defined by a Berlin Score \< 2
- Central sleep apnea, with \>50% of respiratory events classified as central apneas
- Refusal to consider PAP use after an initial split-night PAP study (pre-randomization)
- Concurrent involvement in another research study that will result in a conflict as determined by study doctors
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01261390
Start Date
March 1 2011
End Date
March 1 2014
Last Update
May 30 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115