N/A
Completed N=76
Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD
Source: ClinicalTrials.gov NCT02641496 ↗Enrolled (actual)
76
Serious AEs
2.6%
Results posted
Jul 2024
Primary outcomePrimary: Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night — 234.00; 144.25; 157.04; 152.39 minutes per night — p=0.027
Summary
Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high comorbidity of these risk factors in Veterans, OSA presents a significant health burden to Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of Vietnam-era Veterans with Posttraumatic Stress Disorder (PTSD). OSA is easily treated; however, 15-30% of OSA patients are non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment. The proposed research aims to facilitate adherence to CPAP treatment by testing a novel cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night |
234.00; 144.25; 157.04; 152.39 | 0.027 sig |
| SECONDARY Functional Outcomes of Sleep Questionnaire (FOSQ) |
15.77; 15.10 | 0.696 |
| SECONDARY California Verbal Learning Test, Second Edition (CVLT-II) |
9.00; 8.48 | 0.593 |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) |
27.31; 26.82 | 0.925 |
Eligibility Criteria
Inclusion Criteria
- Male or Female Veterans of any racial or ethnic group
- Age 18 years old and older
- OSA diagnosis by a board-certified Sleep Medicine physician
- Have PTSD
- Capable of giving informed consent for the study; able to read and write English; willing and able to comply with study requirements and restrictions
- Not have a cognitive disorder
- Sufficient visual and auditory acuity for cognitive testing
- No new medication(s) within the prior 1 month. If on a non-excluded medication for a non-excluded condition, the medication regimen will be stable (no changes in dose) for at least 1 month prior to baseline (including anti-hypertensive and diabetic medications).
Exclusion Criteria
Sleep
- Current CPAP usage, home oxygen therapy, tracheotomy or past corrective surgery for OSA (e.g., uvulopalatopharyngo-plasty, midline glossectomy, or lingualplasty).
- Diagnosis of Central Sleep Apnea (CSA)
- Comorbid sleep disorder
- Working night, rotating or split [period of work, followed by break, and then return to work]; shift work within 1-month of screening or plan to work these shifts during study; Occupations where participants regularly experience jet lag or have irregular work schedules.
Other Medical
- Unstable or moderate to severe chronic illness including systolic congestive heart failure, uncontrolled asthma, severe liver disease, end stage renal disease requiring hemodialysis or history of systemic illness affecting central nervous system (CNS) function (e.g. liver failure, kidney failure, congestive heart failure, systemic cancer).
- Any current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable. Any solid organ transplantation.
- Known or suspected neuromuscular disease (e.g. amyotrophic lateral sclerosis, spinal cord injury)
- History of head injury within past year, or history of loss of consciousness > 24 hours
- History of other neurological disease
- Certain medications
- Judged by the investigators to be unable or unlikely to follow the study protocol.
Psychiatric
- Primary psychotic disorder
- Bipolar disorder
- Prominent suicidal or homicidal ideation
- Current exposure to trauma, or exposure to trauma in the past 3 months
- Some substance use
- Presence of acute or unstable psychiatric condition(s) that requires referral for treatment.
- Current or expected cognitive behavior therapy for another condition (e.g. insomnia, anxiety).
Other
- A clinical history or participation in other research that would interfere with the objectives of this study.
- Any other medical, social, or geographical factor that would make it unlikely that the participant would comply with the study procedures.
Data sourced from ClinicalTrials.gov (NCT02641496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.