Addressing Insufficient PAP Use in Older Veterans

NCT04868682 | Completed Results

• 1 other identifier: IIR 20-046
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea

Keywords

sleep apnea; positive airway pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sleep Quality

  6 months following randomization

• Daytime Sleepiness

  6 months following randomization

• Sleep-related Function

  6 months following randomization

Study Arms (2)

PAP Adherence Program

EXPERIMENTAL

Manual-based behavioral treatment to improve PAP adherence and sleep.

Behavioral: PAP Adherence Program

Active Control

ACTIVE COMPARATOR

Manual-based general sleep education program.

Behavioral: Active Control

Interventions

PAP Adherence Program BEHAVIORAL

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.

PAP Adherence Program

Active Control BEHAVIORAL

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.

Active Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

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

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

Results Point of Contact

• Title: Dr. Cathy Alessi
• Organization: VA Greater Los Angeles Healthcare System

cathy.alessi@va.gov

818 891-7711

Study Officials

• Cathy A. Alessi, MD

  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: Neither the participant or staff who conduct the follow-up assessments will be aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: January 10, 2022
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)