Sleep Apnea Intervention for Cardiovascular Disease Reduction — BestAIR  

Obstructive Sleep Apnea Clinical Trial

Official title: A Planning Study: Sleep Apnea Intervention for Cardiovascular Disease Reduction

Status Active, not recruiting

Clinical Trial 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 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.

A sleep doctor or cardiologist 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.

*For those randomized after December 31, 2012, the study will be 6 months long.

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

Clinical Trial 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 severe obstructive sleep apnea (OSA) presenting to a sleep disorders clinic. A total of 700 patients with a new diagnosis of moderate to severe OSA will be recruited from BWH-affiliated sleep disorder clinics, BWH, MGH, and Faulkner Hospital Cardiology Clinics (and similar specialized clinics seeing patients with cardiovascular risk factors, such as endocrinology and hypertensive clinics), Beth Israel Deaconess Medical Center and Joslin Diabetes Center. After completing a 2 week run-in period, randomized participants (approximately 150 participants will be randomized) will undergo baseline and 6 month assessments of key study exposure and outcome variables.

Participants will be randomized after completion of Baseline visit. The treatment arms are as follows:

The active groups are:

• Active CPAP treatment delivered using standard respiratory therapist (RT) adherence education and support

• Active CPAP treatment administered using adherence education and support delivered by a RT and enhanced by a behavioral promotion intervention

The control arms are:

• Sham-CPAP

• CMT, alone

Participants randomized before December 31, 2012 (n=108) also will undergo 12 month follow-up assessments. Participants will be offered a 12 month supervised conservative medical therapy (CMT) program for OSA over the duration of the study intervention. Subjects would be contacted at bimonthly intervals by alternating phone and office visits to assess safety, identify adverse events, identify health care utilization, and reinforce protocol adherence. At 6 and 12 months, study outcomes will be reassessed by collecting data from sources.

Patients randomized after December 31, 2012 will undergo only 6 months of follow-up assessment. Participants will be offered a 6 month supervised conservative medical therapy (CMT) program for OSA over the duration of the study intervention. Subjects would be contacted at bimonthly intervals by alternating phone and office visits to assess safety, identify adverse events, identify health care utilization, and reinforce protocol adherence. At 6 months, study outcomes will be reassessed by collecting data from sources. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Diseases
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT01261390
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2011
• Completion date: March 2014