N/A Completed N=90 Randomized Double-blind Treatment

Treating Sleep Apnea in Women Veterans

sleep apnea

Source: ClinicalTrials.gov NCT03377452 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcomePrimary: PAP Adherence — 32.9; 25.67 Number of nights — p=0.2313

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY PAP Adherence	32.9; 25.67	0.2313
PRIMARY Sleep Quality by Patient-reported Sleep Questionnaire	9.41; 9.11; 6.37; 9.39	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Community-dwelling women Veterans aged 18 years and older
Received care from a Veterans Health Administration (VHA) facility
Have a least one risk factor for sleep apnea (e.g., hypertension, obesity, or age 50 years or older)
Diagnosed as having sleep apnea with an AHI of 5 or greater

Exclusion Criteria

Currently using a treatment for sleep apnea
Current pregnancy
Active substance user or in recovery with < 90 days of sobriety
Too ill to engage in study procedures
Do not have transportation to the medical center
Unable to self-consent (e.g., due to cognitive impairment)
Unstable housing
Does not have sleep apnea
Another sleep disorder (e.g., restless legs syndrome, circadian rhythm sleep disorder) accounts for sleep disturbance
No sleep complaints or symptoms

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Data sourced from ClinicalTrials.gov (NCT03377452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.