N/A
Completed N=42
A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder
Source: ClinicalTrials.gov NCT01569022 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Residual Apnea Hypopnea Index — 3.9; 26.3 events per hour — p=<0.001
Summary
Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict oral appliance response
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Apnea Hypopnea Index |
3.9; 26.3 | <0.001 sig |
| SECONDARY Health Outcomes |
9.4; 9.5; 49.9; 50.03; 17.3; 17.3 | 0.97 |
| SECONDARY General Health SF-36 |
49.33; 50.58 | 0.54 |
| SECONDARY Adherence to Therapy |
3.4; 5.66 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Consecutive patients aged 18-70 years of age
- Documented obstructive sleep apnea by polysomnography (AHI 5 or more/hr)
- Established diagnosis of PTSD related to any past lifetime traumatic event and have a diagnosis of current, chronic PTSD
Exclusion Criteria
- Central sleep apnea defined as central apnea/hypopnea >50% of the total respiratory events
- Prior treatment for sleep apnea
- Veterans with fewer than 4 teeth remaining in either arch
- Coexisting narcolepsy
- Tempo-mandibular joint disease
- Epilepsy
- Prominent suicidal or homicidal ideation
- Diagnosis of dementia
Data sourced from ClinicalTrials.gov (NCT01569022). 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.