Addressing Insufficient PAP Use in Older Veterans

Addressing Insufficient Positive Airway Pressure Use Among Older Veterans With Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a common problem among middle-aged and older Veterans that is associated with poor nighttime sleep, more daytime sleepiness, poor functioning and worse quality of life. The recommended therapy for most patients with OSA is positive airway pressure (PAP) therapy; however, over time many patients prescribed PAP therapy no longer use it regularly. This study will test the effects of an behavioral treatment specifically designed for middle-aged and older Veterans who have stopped using their PAP device, or are not using it regularly.

Eligible Veterans who are enrolled into the study will receive a baseline assessment that includes questionnaires about sleep, health, and quality of life. After completing the baseline assessment, participants will be randomly assigned to one of two groups. Both groups will meet individually with a "sleep coach" for 5 session over 8 weeks, then they will be contacted by the sleep coach monthly by telephone for up to 6 months. Participants will complete follow-up assessments immediately after the fifth education session and again at 6-months and 12-months.

If successful, this approach has the potential to improve sleep, function and quality of life in middle-aged and older Veterans with OSA.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Behavioral: PAP Adherence Program; Behavioral: Active Control

Detailed Description

Background: The most frequently diagnosed sleep disorder among middle-aged and older Veterans is obstructive sleep apnea (OSA), which is associated with serious adverse effects on health, quality of life and survival. Positive airway pressure (PAP) is recommended as first-line treatment (particularly for moderate to severe OSA), but sustained use is difficult to achieve, including among middle-aged and older Veterans, and nearly half of patients with OSA who begin PAP therapy discontinue use within a year.

Significance/Impact: Although OSA is a chronic condition, research to date has primarily focused on increasing initial PAP use in patients with newly diagnosed OSA. In addition, most research has not addressed PAP use in older adults, which is unfortunate given the high prevalence and important adverse effects of OSA on their health and well-being. Prior work suggests that behavioral interventions are effective in improving initial PAP use, but little is known of how to address insufficient PAP use over time.

Innovation: To address this problem, the investigators developed and pilot-tested a structured, manual-based behavioral treatment to address insufficient PAP use among middle-aged and older adults with previously diagnosed OSA. The intervention (5 individual virtual sessions over 8 weeks, then monthly brief telephone contact for up to 6 months) is designed so it can be provided by individuals ("sleep coaches") from various disciplines (supervised remotely by a psychologist) in a variety of settings for maximal implementation.

Specific Aims: Primary Aim 1 will test the efficacy of this intervention for improving PAP usage among middle-aged and older Veterans with previously diagnosed moderate or severe OSA who have insufficient PAP use. The hypotheses are that the intervention will increase objectively measured PAP use over 6-months follow-up, with effects sustained over 12 months. Secondary Aim 2 will test for effects on sleep quality, daytime sleepiness and sleep-related function; and Exploratory Aim 3 will test for effects on health-related quality of life. The hypotheses are that these outcomes will also improve at 6 months, and effects will be sustained at 12 months.

Methodology: The investigators are conducting a randomized, controlled trial to test this new intervention in middle-aged and older Veterans (N=106) with previously diagnosed OSA (moderate or severe) who were prescribed PAP, but have insufficient PAP use (defined as no PAP use over the prior 30 days). Participants will be randomized to one of two groups. Structured assessments at baseline, post-treatment (after session 5) and 6- and 12-months follow-up include objectively measured PAP use (via remote telemonitoring), sleep quality, daytime sleepiness, sleep-related function and health-related quality of life. The investigators will also collect participant experiences and attitudes related to the intervention, and implementation outcome measures (e.g., acceptability, appropriateness, fidelity and staff time as an estimate of cost) to inform future implementation.

Implementation/Next Steps: The long-term goal of this work is to effectively address insufficient PAP use among middle-aged and older Veterans with OSA to improve their sleep and quality of life. If successful, the investigators will develop an implementation package to promote wider implementation of this model of care into clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sepulveda, California, United States, 91343
      • VA Greater Los Angeles Healthcare System, Sepulveda, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of moderate to severe obstructive sleep apnea (apnea hypopnea index [AHI] > or = 15)
• Previously prescribed positive airway pressure (PAP) therapy
• Insufficient PAP use (defined as no PAP use over the past 30 days)

Exclusion Criteria:

• Severe psychopathology (e.g., active psychosis) that precludes participation in the study
• Severe unstable medical illness that precludes participation in the study
• Significant cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAP Adherence Program; Manual-based behavioral treatment to improve PAP adherence and sleep.	Behavioral: PAP Adherence Program; Manual-based treatment focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep. The intervention involves five individual virtual sessions provided by allied health personnel, with brief monthly telephone contact for up to 6 months. Allied health personnel have regular supervision with a behavioral sleep medicine psychologist.
Active Comparator: Active Control; Manual-based general sleep education program.	Behavioral: Active Control; Manual-based general sleep education program. The active control involves five individual virtual sessions provided by allied health personnel, with brief monthly telephone contact for up to 6 months. Allied health personnel have regular supervision with a study clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAP Adherence	Mean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.	Nights 1 to 180 following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months following randomization
Daytime Sleepiness	Total score on the Epworth Sleepiness Scale will be used as a measure of daytime sleepiness. Score range from 0-24. Higher scores indicate worse outcome.	6 months following randomization
Sleep-related Function	Total score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be used as a measure of sleep-related function. Scores range from 5-20. Lower scores indicate worse outcome.	6 months following randomization

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Cathy A. Alessi, MD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: sleep apnea; positive airway pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes
• Other Study ID Numbers: IIR 20-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No