Post Traumatic Stress DisorderNCT05156112
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
A study testing Positive Airway Pressure Device in people with Post Traumatic Stress Disorder and Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Obstructive Sleep Apnea, Substance Use Disorder
- What is being tested?
- Positive Airway Pressure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 31 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a Veteran of the U.S. military or Reserve/National Guard member
- have an Apnea Hypopnea Index (AHI) 5 per hour
- experienced trauma that occurred in childhood or adulthood; at least one month post-trauma
- have current DSM-5 diagnoses of substance use disorder (SUD) via Structured Clinical Interview for DSM-Substance Use Disorders (SCID-SUD) module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back)
- Full post-traumatic stress disorder (PTSD) diagnosis via clinician administered post-traumatic stress disorder (PTSD) scale
- are literate in English
- are on the post-traumatic stress disorder (PTSD) track of the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) unit
- are capable of giving informed consent
Who cannot join
- have central sleep apnea (Apnea Hypopnea Index (AHI)>=5 and > 50% central apneas)
- arrives on the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) unit already using a positive airway pressure (PAP) device (Veteran's previously diagnosed with OSA, but not using positive airway pressure (PAP) therapy will be eligible)
- the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via Montreal Cognitive Assessment (MOCA) < 26)
- history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Peter Colvonen, PhD, (858) 552-8585 ext. 2468, peter.colvonen@va.gov
Peter Colvonen, PhD
About this study
Official title: Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program
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.
Read the detailed description
Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having one condition worsens the course of the other. Individuals with both disorders exhibit worse functioning across a number of domains than individuals with either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Compared to Veterans with a single disorder, Veterans with SUD/PTSD also are more likely to have suicidal ideation and to have attempted suicide. Examining treatable conditions that are associated with improved SUD and PTSD outcomes, such as obstructive sleep apnea (OSA), can maximize treatment efficacy for Veterans at a critical time in recovery.
OSA is highly comorbid with both PTSD and SUD with upwards of 67 to 83% of Veterans with SUD or PTSD also having OSA. Further, untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, and higher substance use and relapse rates. Importantly, untreated OSA also contributes to higher suicide attempts and completion. Positive airway pressure (PAP) is the gold standard treatment for OSA with large effects on multiple domains of functioning, quality of life, PTSD symptoms, physical functioning, lower depression, and better emotional coping. Unfortunately, screening and treating Veterans for OSA is not a part of clinical practice for SUD or PTSD treatment; as such the average wait time for individuals to get PAP therapy is upward of two years. Despite the widespread dissemination of knowledge regarding the detrimental effects of untreated OSA and the incredible effectiveness of PAP treatment, OSA is rarely screened for or treated in patients with SUD or PTSD, with approximately 80% to 90% of Veterans with OSA remaining undiagnosed and untreated.
Methodology.
The investigators aim to examine the effects of PAP treatment on Veterans with PTSD and SUD on a 28-day residential unit. The investigators are proposing a randomized controlled study comparing two groups: an early intervention PAP treatment group receiving PAP treatment while on the residential unit, compared to a waitlist control group who will receive PAP treatment at 3-months post-discharge follow-up. Participants will be 194 male and female Veterans on the residential SUD and PTSD unit with SUD, PTSD, and OSA. The primary aim is to determine the relative efficacy of PAP treatment on the SUD/PTSD unit, as compared to waitlist control, in reducing problematic substance use, PTSD symptoms, and suicidal ideation, while improving functioning among Veterans with comorbid SUD/PTSD at 3-months post-treatment follow-up. The investigators will also compare PAP adherence rates on PTSD/SUD/functioning outcomes within the PAP treatment group (3-months). Finally, the investigators plan on comparing adherence rates between the two treatment groups at the 6-months post-treatment follow-up assessment.
- Conditions
- Post Traumatic Stress Disorder, Obstructive Sleep Apnea, Substance Use Disorder, Residential Treatment Program
- Being tested
- Positive Airway Pressure Device
- Keywords
- Veteran, PTSD, Obstructive Sleep Apnea, Substance Use Disorder, PAP Treatment, Residential Treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Apnea, Obstructive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure DeviceDevice
Also called PAP; CPAP; Auto-PAP
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).
| Study group | Role | What they receive |
|---|---|---|
| PAP Treatment on SARRTP Unit | Experimental | Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit. Receives: Device: Positive Airway Pressure Device |
| Waitlist Control | No intervention | Veterans will not receive PAP device until after 3-month Follow Up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
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.
Measured: 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
Examining change in percentage of substance use in the past 90 days.
Measured: Baseline, 3-Month Follow up (90 Days)
Change in Clinician Administered PTSD Scale (CAPS-5)
Change in PTSD symptom severity will be assessed using CAPS-5 in the past month. The CAPS-5 is a 30-item structured interview.
Measured: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)
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
Measured: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Secondary outcomes (1)
Positive airway pressure (PAP) adherence rates
Examining average number of nights used positive airway pressure is use over the last 30 days.
Measured: 3-Month Follow up (90 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start2 Jan 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators aim to examine the effects of PAP treatment on Veterans with PTSD and SUD on a 28-day residential unit. The investigators are proposing a randomized controlled study comparing two groups: an early intervention PAP treatment group receiving PAP treatment while on the residential unit, compared to a waitlist control group who will receive PAP treatment at 3-months post-discharge follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter Colvonen, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156112
- Sponsor's protocol ID
- D3623-R
- Other IDs
- 1I01RX003623-01, 5I01RX003623-04
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No