Please select the outcome measures that correspond to the clinical trial below.
Title: A Planning Study: Sleep Apnea Intervention for Cardiovascular Disease Reduction
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 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 (BWH) and Beth Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups:

1. Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical treatment for sleep apnea with active-PAP. Participants will be randomized to either:

   1. Active-Pap with respiratory therapist visits only
   2. Active-Pap with respiratory therapist visits and cognitive behavioral therapist visits.
2. Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP therapy group. Will also have meetings with respiratory therapist.
3. Conservative Medical Therapy Group (CMT)\*: Will receive a free supply of nasal strips for the duration of their treatment period (either 6 months or 12 months) and follow healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences of apneas (breathing disturbances during sleep). Frequent follow-up support with research coordinator.

A sleep doctor or cardiologist will have indicated that a potential participant is an appropriate candidate to receive PAP 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 6-12 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.

We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and mortality.

\*All randomized participants will be given conservative medical therapy (CMT).

\*\*For those randomized after December 31, 2012, follow-up assessment will only be 6 months long


Options:
A: Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms (Mean of 6- and 12-months); Difference in CPAP Adherence by Active Treatment Arm (6-months); Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) (Mean of 6- and 12-months); Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms (12-months); Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms (6-months); Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) (12-months); Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) (6-months)
B: Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea. (6 months)
C: CPAP Adherence (1 month); CPAP Adherence (6 months)
D: Residual Apnea Hypopnea Index (up to 12 weeks)

Answer: A