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

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05156112
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Jan 2, 2023
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Peter Colvonen, PhD
[email protected]
(858) 552-8585
Peter Colvonen, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
PTSD (post-traumatic stress disorder)Substance use disorder
By specialty
PsychiatryMental healthBehavioral healthAddiction medicine
By research site
VA San Diego Healthcare System, San Diego, CA· San Diego, CA

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