PAP Treatment for Sleep Apnea with PTSD and Substance Use Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Central sleep apnea, Severe cognitive impairment, Psychosis, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of this treatment for sleep apnea with PTSD and substance use disorders?
Research shows that using CPAP (a machine that helps keep your airways open while you sleep) can improve PTSD symptoms and reduce nightmares in people with both PTSD and sleep apnea. Studies also suggest that advanced PAP therapies like ABPAP or ASV might help people stick with the treatment better by reducing discomfort.
12345Is PAP treatment safe for people with PTSD and sleep apnea?
PAP treatments like CPAP are generally safe for humans, but people with PTSD and sleep apnea may experience discomfort with the pressure, which can be managed with advanced PAP modes like ABPAP or ASV.
12567How is PAP treatment unique for sleep apnea in patients with PTSD and substance use disorders?
PAP treatment, including advanced modes like auto-bilevel PAP and adaptive servo-ventilation, is unique because it can reduce pressure intolerance and improve adherence in patients with both sleep apnea and PTSD, potentially decreasing PTSD severity and improving sleep quality.
12367Eligibility Criteria
This trial is for U.S. Veterans or Reserve/National Guard members who are at least 18 years old, have PTSD and SUD, can read English, and are in a residential treatment program. They must have experienced trauma and used substances for at least 20 days in the last three months. Those with severe cognitive issues, central sleep apnea, psychosis outside of substance use, or already using PAP devices cannot join.Inclusion Criteria
You have been diagnosed with a substance use disorder and have used substances for at least 20 days in the past 90 days.
You have been diagnosed with PTSD using a specific scale administered by a clinician.
You are currently receiving treatment for PTSD in the SARRTP unit.
+6 more
Exclusion Criteria
You have a history of serious mental health issues like hallucinations or extreme excitement that were not caused by drugs or alcohol.
I have central sleep apnea with more than half of my breathing interruptions being central in nature.
SARRTP medical staff advises against the study based on medical history and physical examination
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Positive Airway Pressure (PAP) treatment while on the 28-day SARRTP Unit
4 weeks
Continuous residential stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, including PAP adherence and functional outcomes
3 months
1 visit (in-person) at 3-month follow-up
Extended Follow-up
Comparison of adherence rates between treatment groups at 6-months post-treatment follow-up
6 months
Participant Groups
The study tests if using a Positive Airway Pressure (PAP) device to treat Obstructive Sleep Apnea (OSA) improves overall function, PTSD symptoms, and substance use outcomes better than waiting for treatment among veterans with both SUD/PTSD in residential care.
2Treatment groups
Experimental Treatment
Active Control
Group I: PAP Treatment on SARRTP UnitExperimental Treatment1 Intervention
Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.
Group II: Waitlist ControlActive Control1 Intervention
Veterans will not receive PAP device until after 3-month Follow Up.
Positive Airway Pressure Device is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Positive Airway Pressure Device for:
- Obstructive Sleep Apnea (OSA)
- Central Sleep Apnea (CSA)
🇪🇺 Approved in European Union as Positive Airway Pressure Device for:
- Obstructive Sleep Apnea (OSA)
- Central Sleep Apnea (CSA)
🇨🇦 Approved in Canada as Positive Airway Pressure Device for:
- Obstructive Sleep Apnea (OSA)
- Central Sleep Apnea (CSA)
🇯🇵 Approved in Japan as Positive Airway Pressure Device for:
- Obstructive Sleep Apnea (OSA)
- Central Sleep Apnea (CSA)
🇦🇺 Approved in Australia as Positive Airway Pressure Device for:
- Obstructive Sleep Apnea (OSA)
- Central Sleep Apnea (CSA)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA San Diego Healthcare System, San Diego, CASan Diego, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Positive airway pressure adherence and subthreshold adherence in posttraumatic stress disorder patients with comorbid sleep apnea. [2022]Patients with comorbid posttraumatic stress disorder (PTSD) and obstructive sleep apnea (OSA) manifest low adherence to continuous positive airway pressure (CPAP) due to fixed, pressure-induced expiratory pressure intolerance (EPI), a subjective symptom and objective sign aggravated by anxiety sensitivity and somatosensory amplification. As advanced PAP therapy modes (ie, auto-bilevel PAP [ABPAP] or adaptive servo-ventilation [ASV]) may address these side effects, we hypothesized such treatment would be associated with decreased expiratory intolerance and increased adherence in posttraumatic stress patients with co-occurring OSA.
Improving PTSD Symptoms and Preventing Progression of Subclinical PTSD to an Overt Disorder by Treating Comorbid OSA With CPAP. [2018]Obstructive sleep apnea (OSA) and posttraumatic stress disorder (PTSD) are common in United States veterans. These conditions often coexist and symptoms overlap. Previous studies reported improvement in PTSD symptoms with continuous positive airway pressure (CPAP) therapy for comorbid OSA but its effect has not been assessed in a non-PTSD cohort. We have prospectively assessed the effect of CPAP therapy on clinical symptom improvement as a function of CPAP compliance levels among PTSD and non-PTSD veterans.
Response to Cognitive Processing Therapy in Veterans With and Without Obstructive Sleep Apnea. [2018]Recent studies have called attention to the need for enhancing treatment outcome in trauma-focused psychotherapies, such as cognitive processing therapy (CPT), with veterans. Given the prevalence of posttraumatic-related sleep disturbances, and the role of sleep in emotional learning and processing, sleep quality may be a target for improving CPT outcome. Elevated rates of obstructive sleep apnea (OSA) have been reported in samples of veterans with posttraumatic stress disorder (PTSD); however, the impact of OSA on response to CPT is unclear. In this study, CPT outcome was examined in veterans with and without a diagnosis of OSA. Following chart review, 68 OSA-positive and 276 OSA-negative veterans were identified. Generalized estimating equations were used to compare between-group differences in weekly self-reported PTSD symptomatology. The OSA-positive veterans reported greater PTSD severity over the course of treatment and at posttreatment compared with veterans without OSA (B = -0.657). Additionally, OSA-positive veterans with access to continuous positive airway pressure (CPAP) therapy reported less PTSD severity relative to OSA-positive veterans without access to CPAP (B = -0.421). Apnea appears to be a contributing factor to the reduced effectiveness of evidence-based psychotherapy for veterans with PTSD; however, preliminary evidence indicates that CPAP therapy may help mitigate the impact of OSA on treatment outcome.
Diagnosing obstructive sleep apnea in a residential treatment program for veterans with substance use disorder and PTSD. [2023]Obstructive sleep apnea (OSA) is often comorbid with both substance use disorders (SUD) and posttraumatic stress disorder (PTSD), yet frequently goes undiagnosed and untreated. We present data on the feasibility and acceptability of objective OSA diagnosis procedures, findings on OSA prevalence, and the relationship between OSA and baseline SUD/PTSD symptoms among veterans in residential treatment for comorbid PTSD/SUD.
The effect of treating obstructive sleep apnea with continuous positive airway pressure on posttraumatic stress disorder: A systematic review and meta-analysis with hypothetical model. [2020]The present study explored whether continuous positive airway pressure (CPAP) treatment impacts nightmare and overall posttraumatic stress disorder (PTSD) symptoms in patients with PTSD and obstructive sleep apnea (OSA). The meta-analysis for six eligibile studies indicates that CPAP can significantly improve nightmare (standardized mean differences (SMD) = -0.778; 95% confidence interval (CI) = -1.228 to -0.327) and overall PTSD symptoms (SMD = -1.298; 95% CI = -2.128 to -0.468) in these patients. A subgroup analysis revealed that the effects of CPAP on improvements of nightmare and overall PTSD symptoms varied across CPAP treatment duration (3 and 6 months), but did not reach a statistically significant level. Furthermore, improvements in overall PTSD symptoms were associated with CPAP adherence. This review emphasizes the importance of the need for a multidisciplinary approach in treating patients with PTSD and OSA, and proposes a hypothetical model of how CPAP improves posttraumatic stress symptoms in patients with PTSD and OSA.
Examining the bidirectional relationship between posttraumatic stress disorder symptom clusters and PAP adherence. [2023]Obstructive sleep apnea (OSA) is a common sleep disturbance in individuals with posttraumatic stress disorder (PTSD), with an emerging literature showing that treating OSA with positive airway pressure (PAP) therapy has a moderate effect on decreasing PTSD severity. Unfortunately, PAP adherence among individuals with PTSD is low. Our study examined how baseline PTSD cluster subscores predict 6-month PAP adherence and how PAP adherence predicts change in PTSD cluster subscores over time.
A Randomized Crossover Trial Evaluating Continuous Positive Airway Pressure Versus Mandibular Advancement Device on Health Outcomes in Veterans With Posttraumatic Stress Disorder. [2018]Despite the overall improvement in posttraumatic stress disorder (PTSD) symptomatology with continuous positive airway pressure (CPAP) therapy, adherence to CPAP is far worse in veterans with PTSD compared to the general population with obstructive sleep apnea (OSA). The aim of this study was to compare the efficacy, adherence, and preference of CPAP versus mandibular advancement device (MAD) and the effect of these treatments on health outcomes in veterans with PTSD.