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

NCT05156112 | Recruiting

• 2 other identifiers: D3623-R1I01RX003623-01
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)

Secondary Outcomes (1)

• PAP adherence rates

  3-Month Follow up (90 Days)

Study Arms (2)

PAP Treatment on SARRTP Unit

EXPERIMENTAL

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

Device: Positive Airway Pressure Device

Waitlist Control

NO INTERVENTION

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

Interventions

Positive Airway Pressure Device 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).

Also known as: PAP; CPAP; Auto-PAP

PAP Treatment on SARRTP Unit

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Apnea, Obstructive; Substance-Related Disorders

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Peter Colvonen, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Colvonen, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessors will be blinded to treatment condition to minimize bias in outcome assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: January 2, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)