Sleep Apnea Intervention for Cardiovascular Disease Reduction

Obstructive Sleep Apnea Clinical Trial

— BestAIR  

Official title:

A Planning Study: Sleep Apnea Intervention for Cardiovascular Disease Reduction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01261390
• Other study ID #: 2010P002671
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 15, 2010
• Last updated: March 4, 2014
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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:

1. Prior myocardial infarction

2. Coronary artery revascularization procedure (=4 months before study entry)

3. Angiographically documented stenosis (>70%) of a major coronary artery

4. Prior ischemic stroke without major functional impairment

5. Diabetes mellitus treated with medication or = 2 fasting glucose levels = 126 mg/dl

OR

Three or more of the following established CVD risk factors:

1. Hypertension treated with medications or systolic BP > 140 or diastolic BP > 90 on = 2 occasions

2. Male sex

3. BMI = 30

4. Total cholesterol > 240 mg/dl or LDL cholesterol > 160 mg/dl or HDL < 45 mg/dl

5. > 10 pack years of smoking

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

• 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

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

Intervention

Behavioral:
• Conservative Medical Therapy
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 (Breath 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.
• Active PAP with Behavioral Modification
In addition to receiving CMT and CPAP specialist-guided adherence support, participants randomized to active PAP with the BPA intervention would meet with a behavioral interventionist at the time of PAP prescription and one week later. Participants also would speak with the behavioral interventionist 6 times over the course of the study: at 3 weeks, 4 weeks, 8 weeks, 12 weeks, 5 months and 8 months after beginning CPAP, or until study follow-up is concluded. The duration of the initial behavioral promotion intervention is estimated to be 45 minutes long, with subsequent interventions 10 to 15 minutes long. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.

Device:
• Sham PAP
In addition to receiving CMT, participants in this treatment arm will receive a sham CPAP 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.
• Active PAP with RT Support
In addition to receiving CMT, participants would be scheduled to meet with the CPAP specialist again one week after initiating PAP to reinforce PAP use and make any adjustments in the mask or pressure setting. Thereafter, the CPAP specialist would meet with the participant in person at months 1, 3, 6, and 9, using the available data from the PAP monitor on PAP use, mask leak, and residual AHI to assist with troubleshooting. Adjustments to equipment (mask replacement, use of chin strap, addition of expiratory pressure release) would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the CPAP specialist would last ~ 15 minutes.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of continuous positive airway pressure therapy on cardiovascular disease, using mean 24 hour systolic blood pressure as the trial's primary endpoint.		3 years	Yes
Secondary	Recruitment and retention rates of patients with moderate to severe obstructive sleep apnea and cardiovascular disease risk factors or established CVD participating in a controlled trial.		3 years	No