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Sleep Apnea Intervention for Cardiovascular Disease Reduction

Sponsored by Brigham and Women's Hospital

Phase Quota
Phase 2

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 problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing heart disease or may already have a diagnosis of heart disease. A clinical research study is being conducted at Brigham and Women's Hospital and Beth Israel Deaconess Medical Center to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups: - CPAP Therapy Group: Standard medical treatment for sleep apnea, with CPAP mask worn during sleep. Participants randomized to either Respiratory Therapist (RT)only or RT with Cognitive Behavioral Therapist. - Alternative CPAP Group: Different air delivery level from mask than CPAP Therapy Group. RT meetings. - Conventional Medical Therapy (CMT) Group: Receive one year supply of nasal strips and follow guidelines for how to change sleep habits to minimize apnea.Frequent follow-up support with research coordinator. The sleep doctor will have indicated that a potential participant is an appropriate candidate to receive CPAP or CMT as acceptable approaches to treat his/her sleep apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed heart disease or between 55-75 years for those who have risk factors for developing heart disease. This is a 12 month study to evaluate alternative ways to address the potential for OSA treatment to reduce heart disease and to identify those features that would strengthen a later, large-scale randomized controlled trial.

Study Start Date: March 2011

Estimated Completion Date: March 2014

Specialties: Cardiology: Diagnostics Internal Medicine: Cardiology,Pulmonology Psychiatry: Psychotherapy/analysis Pulmonology: Apnea/Sleep Disorders Physician Assistant: Cardiology

Interventions

  • Device: Active PAP with Respiratory Therapy Support
  • Behavioral: Active PAP with Behavior Modification
  • Device: Sham PAP
  • Device: Active PAP with RT Support
  • Behavioral: Conservative Medical Therapy
  • Behavioral: Active PAP with Behavioral Modification

Inclusion criteria

  • Obstructive apnea hypopnea index (AHI) >= 15
  • Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)
  • Established CVD, 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 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
    • Diabetes mellitus treated with medication or >= 2 fasting glucose levels >= 126 mg/dl
    • BMI > 30
    • Total cholesterol > 240 mg/dl or LDL cholesterol > 160 mg/dl or HDL < 45 mg/dl
    • > 10 pack years of smoking
  • Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention

Exclusion criteria

  • Diagnosed heart failure with known cardiac ejection fraction of < 35% or NYHA class 3 or 4 status; Less than 4 months since 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 of 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
  • 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)

Study Locations And Contact Information

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