CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03377452
NCT03377452N/ACompleted

Diagnosis and Treatment of Sleep Apnea in Women Veterans

VA Office of Research and Development·interventional·Posted Dec 19, 2017·Updated May 24, 2024

In Brief

A clinical study evaluating Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) and Non-directive sleep apnea education control for Sleep Apnea. Completed, enrolled 90 participants across 1 site.

Detailed Summary

This study is a randomized controlled trial (RCT) to test two sleep apnea education programs for women Veterans newly diagnosed with sleep apnea (SA) who are prescribed positive airway pressure (PAP) therapy. This education program is designed to improve participants' sleep quality and help them to adjust to PAP therapy. Participants undergo a sleep and health assessment that is performed prior to beginning the education program. This assessment includes wearing a wrist actigraph to measure sleep and wake periods for 7 days and nights, and answering questionnaires about sleep habits and health. Participants are randomly assigned to one of two 6-week programs (intervention or educational control) provided by a study interventionist. Follow-up sleep and health assessments will be conducted at the end of the 6-week program and 3-months later. PAP usage data will be collected remotely for 6-months from PAP therapy initiation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 19, 2017
Enrollment StartJun 26, 2018
Primary CompletionMar 31, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.5 years ago

Interventions

Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA)behavioral

Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth.

Non-directive sleep apnea education controlbehavioral

Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.