PAP Treatment for Veterans with SUD and PTSD

This study is looking at whether using a Positive Airway Pressure (PAP) device can help Veterans who are in a residential treatment program for both substance use disorder (SUD) and post-traumatic stress disorder (PTSD). Many Veterans with SUD and PTSD also have obstructive sleep apnea (OSA), and treating OSA might improve their overall recovery. The study will measure changes in disability, substance use, and PTSD symptoms over about three months to see if PAP treatment is helpful. You might be able to join if you are a Veteran, at least 18 years old, have OSA, and have current diagnoses of SUD and PTSD.

Study design
This interventional study plans to enroll 194 participants. The status of the study is currently unclear.
What's involved
Participants will receive PAP treatment, including mask fitting and education. Their disability, substance use, and PTSD symptoms will be measured at the start, after 28 days, and again after 90 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days after starting the study.

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NCT05156112

OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~194 participants
Updated 2025-11-03 on ClinicalTrials.gov
What's tested:Positive Airway Pressure Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Measured over Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
+3 more outcomes measured
Post Traumatic Stress Disorder
Obstructive Sleep Apnea
Substance Use Disorder
Residential Treatment Program
1 sites across 1 states
California1
  • Peter Colvonen, PhD · PRINCIPAL_INVESTIGATOR · VA San Diego Healthcare System, San Diego, CA

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Eligibility criteria

Inclusion

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

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
  • Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)

    Change in functional impairment across multiple domains. The WHODAS 2.0 is a 36-item questionnaire that assess functional impairment across 5 subscales: cognitions (understanding and communicating), mobility, self-care getting along with others, household responsibilities, work responsibilities, and community participation.

  • Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 daysBaseline, 3-Month Follow up (90 Days)

    Examining change in percentage of substance use in the past 90 days.

  • Change in Clinician Administered PTSD Scale (CAPS-5)Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)

    Change in PTSD symptom severity will be assessed using CAPS-5 in the past month. The CAPS-5 is a 30-item structured interview.

  • Change in The Columbia-Suicide Severity Rating Scale (C-SSRS)Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)

    Change in suicidal ideation severity using the C-SSRS. The C-SSRS is a standardized 8-point clinician-administered suicidal rating system designed to track suicidal adverse events across a treatment trial and covering the wide spectrum of suicidality