Recruiting

PAP Treatment

Sponsor:

VA Office of Research and Development

Code:

NCT05156112

Conditions

Post Traumatic Stress Disorder

Obstructive Sleep Apnea

Substance Use Disorder

Residential Treatment Program

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positive Airway Pressure Device

Study Details

Brief summary:

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.

Conditions

Post Traumatic Stress Disorder

Obstructive Sleep Apnea

Substance Use Disorder

Residential Treatment Program

Study ID

NCT05156112

Start date

Jan 2, 2023

Status verified date

Oct, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • a Veteran of the U.S. military or Reserve/National Guard member
  • at least 18 years of age
  • have an AHI 5 per hour
  • experienced trauma that occurred in childhood or adulthood; at least one month post-trauma
  • have current DSM-5 diagnoses of SUD via SCID-SUD module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back)
  • Full PTSD diagnosis via clinician administered PTSD scale
  • are literate in English
  • are on the PTSD track of the SARRTP unit
  • are capable of giving informed consent

Exclusion Criteria:

  • have central sleep apnea (AHI >=5 and > 50% central apneas)
  • arrives on the SARRTP unit already using a PAP device (Veteran's previously diagnosed with OSA, but not using PAP therapy will be eligible)
  • the SARRTP medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via MOCA < 26)
  • history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress

Study Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PAP Treatment on SARRTP Unit

Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.

no intervention: Waitlist Control

Veterans will not receive PAP device until after 3-month Follow Up.

Interventions

Positive Airway Pressure Device

Each PAP treatment initiation meeting will include 1) mask fitting; 2) psycho-education to what to expect and reviewing PAP machine problem solving; and 3) setting up correct PAP treatment (e.g., auto PAP or in rare conditions, bi-level PAP).

Primary outcome measure

  • Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days) ]
  • Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days [ Time Frame: Baseline, 3-Month Follow up (90 Days) ]
  • Change in Clinician Administered PTSD Scale (CAPS-5) [ Time Frame: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days) ]
  • Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days) ]

Central Contacts and Locations

Central contacts

Peter Colvonen, PhD

(858) 552-8585peter.colvonen@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Peter Colvonen, PhD

(858) 552-8585peter.colvonen@va.gov

Principal Investigator:

Peter Colvonen, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Keywords

  • Veteran
  • PTSD
  • Obstructive Sleep Apnea
  • Substance Use Disorder
  • PAP Treatment
  • Residential Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-03.