A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01535586

Enrollment

Registered

2012-02-17

Start date

2012-04-30

Completion date

Unknown

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

CPAP, MAD, sleep apnea, PTSD

Brief 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 mandibular advancing devices-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 MAD response.

Interventions

DEVICECPAP versus MAD

Cross over design

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	12 weeks	The primary objective of this trial is to assess the efficacy of MAD versus CPAP in the treatment of OSA in Veterans with PTSD.Treatment will be considered efficacious (successful) when the apnea-hypopnea index is \< 5 in the absence of hypoxemia defined as SvO2\<90%.

Secondary

Measure	Time frame	Description
Adherence	12 weeks	Adequate adherence will be defined as device usage of \>4 hr per night for 70% of days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026