Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment

Brigham and Women's Hospital40 enrolled

Overview

The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education.

The study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). Participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning CPAP and the other occurring two weeks later. Participants in the individual education (comparator) arm will begin CPAP without attendance at any peer-support sessions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive

Interventions

CPAP + Peer SupportBEHAVIORAL

CPAP + Individual EducationBEHAVIORAL

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with obstructive sleep apnea (no cut-off for severity) * Prescribed continuous positive airway pressure Exclusion Criteria: * Not fluent in English * Prior CPAP use at home * Current use of any non-CPAP treatment for obstructive sleep apnea * A co-morbid sleep disorder * Use of supplemental oxygen * A clinical need for urgent CPAP therapy

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Adherence

Objective adherence to CPAP, measured in hours per night.

Time frame: 6 weeks

Secondary Outcomes

Percentage of Participants With Adherence >=4 Hours/Night on Average

Objective adherence to CPAP, percentage with adherence \>=4 hours/night on average

Time frame: 6 weeks

FOSQ

Functional Outcomes of Sleep Questionnaire. The FOSQ is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep.

Time frame: 6 weeks

SEMSA - Perceived Risk

Self Efficacy Measure for Sleep Apnea - Perceived Risk The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of perceived risk associated with sleep apnea.

Time frame: 6 weeks

SEMSA - Outcome Expectations

Self Efficacy Measure for Sleep Apnea - Outcome Expectations. The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of outcome expectations associated with treatment of sleep apnea.

Time frame: 6 weeks

SEMSA - Self Efficacy

Self Efficacy Measure for Sleep Apnea - Self Efficacy The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of self efficacy associated with treatment of sleep apnea.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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