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Completed

NCT Number: NCT02538419

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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP + Peer Support

Behavioral

CPAP + Individual Education

Behavioral

Primary outcomes

  1. Adherence

    Time frame: 6 weeks

    Objective adherence to CPAP, measured in hours per night.

Secondary outcomes

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

    Time frame: 6 weeks

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

  2. FOSQ

    Time frame: 6 weeks

    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.

  3. SEMSA - Perceived Risk

    Time frame: 6 weeks

    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.

  4. SEMSA - Outcome Expectations

    Time frame: 6 weeks

    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.

  5. SEMSA - Self Efficacy

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2015
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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