NCT05156112 · VA Office of Research and Development
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
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 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 days
Time frame: Baseline, 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)
Time frame: 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)
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 3, 2025 · Source of record for eligibility and locations