Overview

This trial is active, not recruiting.

Condition sleep apnea, obstructive
Treatments peer support, individual education
Phase phase 2
Sponsor Brigham and Women's Hospital
Start date October 2015
End date September 2016
Trial size 45 participants
Trial identifier NCT02538419, 2014P002326

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
peer support
(Active Comparator)
Participants randomized to this arm will receive individual support and education from a trained investigator.
individual education

Primary Outcomes

Measure
Adherence
time frame: 6 weeks

Secondary Outcomes

Measure
FOSQ
time frame: 6 weeks
SEMSA
time frame: 6 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.