Treating Sleep Apnea in Women Veterans

NCT03377452 | Completed Results

• 1 other identifier: IIR 16-244
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• PAP Adherence

  Number of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Number of nights range from 0 to 90 nights. More nights indicate better outcome. Remote monitoring data were available for all participants even if lost to follow-up for other measures. The sample size for this outcome is larger than for other outcomes as a result.

  Three months after PAP initiation

• Sleep Quality by Patient-reported Sleep Questionnaire

  Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of sleep quality. Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome. This measure is available only for participants who were not lost to follow-up.

  Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session)

Study Arms (2)

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

EXPERIMENTAL

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.

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

Non-directive sleep apnea education control

ACTIVE COMPARATOR

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

Behavioral: Non-directive sleep apnea education control

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.

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

Non-directive sleep apnea education control BEHAVIORAL

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

Non-directive sleep apnea education control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is for women Veterans.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

Related Publications (6)

• Moghtaderi I, Kelly MR, Carlson GC, Fung CH, Josephson KR, Song Y, Swistun D, Zhu R, Mitchell M, Lee D, Badr MS, Washington DL, Yano EM, Alessi CA, Zeidler MR, Martin JL. Identifying gaps in clinical evaluation and treatment of sleep-disordered breathing in women veterans. Sleep Breath. 2023 Oct;27(5):1929-1933. doi: 10.1007/s11325-022-02765-1. Epub 2022 Dec 16.

  PMID: 36525174 RESULT

• Saldana KS, McGowan SK, Martin JL. Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. Sleep Med Clin. 2023 Mar;18(1):73-83. doi: 10.1016/j.jsmc.2022.09.003.

  PMID: 36764788 RESULT

• Carlson GC, Kelly MR, Grinberg AM, Mitchell M, McGowan SK, Culver NC, Kay M, Alessi CA, Washington DL, Yano EM, Martin JL. Insomnia Precipitating Events among Women Veterans: The Impact of Traumatic and Nontraumatic Events on Sleep and Mental Health Symptoms. Behav Sleep Med. 2021 Sep-Oct;19(5):672-688. doi: 10.1080/15402002.2020.1846537. Epub 2020 Nov 30.

  PMID: 33251855 RESULT

• Carlson GC, Kelly MR, Mitchell M, Josephson KR, McGowan SK, Culver NC, Kay M, Alessi CA, Fung CH, Washington DL, Hamilton A, Yano EM, Martin JL. Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. Womens Health Issues. 2022 Mar-Apr;32(2):194-202. doi: 10.1016/j.whi.2021.10.007. Epub 2021 Nov 21.

  PMID: 34815139 RESULT

• Saldana KS, Carlson GC, Revolorio K, Kelly MR, Josephson KR, Mitchell MN, Culver N, Kay M, McGowan SK, Song Y, Deleeuw C, Martin JL. Values Expressed by Women Veterans Receiving Treatment for Chronic Insomnia Disorder. Behav Sleep Med. 2024 May-Jun;22(3):340-352. doi: 10.1080/15402002.2023.2260517. Epub 2023 Sep 25.

  PMID: 37749876 RESULT

• Ravyts SG, Erickson AJ, Washington DL, Yano EM, Carlson GC, Mitchell MN, Kelly M, Alessi CA, McGowan SK, Song Y, Martin JL, Dzierzewski JM. A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes. J Psychosom Res. 2023 Dec;175:111536. doi: 10.1016/j.jpsychores.2023.111536. Epub 2023 Oct 21.

  PMID: 37913677 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study transitioned from in-person to telehealth visits during the COVID-19 pandemic. As a result, actigraphy could not be collected from some participants and the target sample size was not achieved for this secondary outcome. PAP devices used in the trial were recalled by the manufacturer during the final year of enrollment. Impacted participants were contacted and provided assistance. PAP devices from a different manufacturer were purchased for remaining participants.

Results Point of Contact

• Title: Jennifer Martin, PhD
• Organization: VA Greater Los Angeles Healthcare System

jennifer.martin@va.gov

818-891-7711

Study Officials

• Jennifer L Martin, PhD

  VA Greater Los Angeles Healthcare System, Sepulveda, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Individuals will be assigned to one of two programs simultaneously

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: June 26, 2018
• Primary Completion: March 31, 2022
• Study Completion: November 30, 2022
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)