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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: PAP Treatment on SARRTP UnitExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
2

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.

Time frame
Baseline, 3-Month Follow up (90 Days)
3

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.

Time frame
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
4

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

Time frame
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.

Time frame
3-Month Follow up (90 Days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.