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

• ClinicalTrials.gov Identifier: NCT05156112
• Recruitment Status: Recruiting
• First Posted: December 14, 2021
• Last Update Posted: January 17, 2023
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: November 30, 2021
• First Posted Date: December 14, 2021
• Last Update Posted Date: January 17, 2023
• Actual Study Start Date: January 2, 2023
• Estimated Primary Completion Date: May 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 30, 2021)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 30, 2021)

PAP adherence rates [ Time Frame: 3-Month Follow up (90 Days) ]

Examining average number of nights used positive airway pressure is use over the last 30 days.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
• Official Title: Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:

All assessors will be blinded to treatment condition to minimize bias in outcome assessments

Primary Purpose: Treatment

Condition

• Post Traumatic Stress Disorder
• Obstructive Sleep Apnea
• Substance Use Disorder
• Residential Treatment Program

Intervention

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).

Other Name: PAP; CPAP; Auto-PAP

Study Arms

• Experimental: PAP Treatment on SARRTP Unit
  Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.
  Intervention: Device: Positive Airway Pressure Device
• No Intervention: Waitlist Control
  Veterans will not receive PAP device until after 3-month Follow Up.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 30, 2021): 194
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2027
• Estimated Primary Completion Date: May 31, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Peter Colvonen, PhD; (858) 552-8585 ext 2468; peter.colvonen@va.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05156112
• Other Study ID Numbers: D3623-R; 1I01RX003623-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter Colvonen, PhD; VA San Diego Healthcare System, San Diego, CA

• PRS Account: VA Office of Research and Development
• Verification Date: January 2023