Sleep Apnea Intervention for Cardiovascular Disease Reduction
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cardiovascular Diseases
Study type: Interventional

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
    

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 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, Massachusetts General Hospital (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 arms are:

        1. Active-PAP treatment delivered using standard respiratory therapist (RT) adherence
           education and support. (Active-Beh)

        2. Active-PAP treatment administered using adherence education and support delivered by a
           RT and enhanced by a behavioral promotion intervention. (Active+Beh)

      The control arms are:

        1. Conservative Medical Therapy (CMT)

        2. Sham-PAP (Sham)

      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 (n=61) 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.
    

Intervention name(s): Conservative Medical Therapy (CMT); Sham PAP (Sham); Active PAP with RT Support (Active-Beh); Active PAP with Behavioral Modification (Active+Beh)
Intervention type(s): Behavioral; Device; Device; Device
Intervention description(s): All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.; In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.; In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The CPAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.; In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Other intervention name(s): Breathe Right® external dilator strips; REMstar Pro M Series (Philips-Respironics); S9 (ResMed); REMstar Pro M Series (Philips-Respironics); S9 (ResMed); REMstar Pro M Series (Philips-Respironics); S9 (ResMed)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Apnea; Heart Disease; Risk factors for heart disease