A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Psychiatric, Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/10/2017 |
| Start Date: | November 1, 2012 |
| End Date: | March 30, 2017 |
A Randomized Cross Over Trial of Two Treatments for OSA in Veterans With PTSD
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
(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
Obstructive sleep apnea (OSA) is a prevalent disorder associated with poor neurocognitive
performance and organ system dysfunction due to intermittent hypoxia and repeated arousals.
The repetitive hemodynamic stresses are implicated in the increased incidence of systemic
hypertension and cardiovascular diseases. Insufficient and disrupted sleep has similar
negative impact on mood, attention, cognition, and behavior. In Veterans with post traumatic
stress disorder (PTSD), the disturbed sleep can worsen further the cognitive-behavioral
manifestations of PTSD and contributes to poor mental and physical health outcomes. Recent
epidemiologic studies largely support the association of higher rates of OSA in patients with
PTSD compared with the general population. Treatment of the underlying obstructive sleep
disturbances with continuous positive airway pressure (CPAP) has resulted in restoration of
sleep architecture, decrease daytime sleepiness, and reduction in nightmares frequency and
intensity. However, adherence to treatment with CPAP is less than optimal in Veterans with
PTSD. Mandibular advancing devices (MADs) are considered non surgical alternatives to CPAP
and are preferred in a head to head comparison to CPAP in OSA subjects without PTSD. However,
there has been no study to the investigators' knowledge that has assessed MAD in terms of
clinical efficacy, compliance, and quality of sleep compared to CPAP in OSA patients with
PTSD. Therefore, the investigators hypothesize that MAD is not inferior to CPAP in treating
OSA effectively in Veterans with PTSD and OSA. To that end, the investigators propose to
conduct a feasibility study using a randomized crossover trial of 12 weeks of CPAP and MAD in
42 consecutive outpatients with PTSD newly diagnosed with OSA separated by 2 weeks washout
period.
The primary endpoint of the trial is to compare the treatment efficacy of CPAP and MAD in
Veterans with PTSD and OSA. Secondary endpoints aim at: 1) comparing change in the Epworth
Sleepiness Scale, SF-36, and the Pittsburgh Sleep Quality Index at end of treatment following
use of CPAP versus MAD, 2) comparing adherence and short-term side effects between using CPAP
and MAD in PTSD patients with OSA, and 3) determining anthropomorphic, polysomnographic, and
cephalometric predictors of successful MDA response. Assessments at the end of both limbs
comprise evaluation of quality of sleep, daytime sleepiness, quality of life, and side
effects of treatment. Compliance with each therapy will be measured at the end of each
treatment period.
The results of the trial are pivotal in determining the efficacy, tolerability, and adherence
to MAD compared to CPAP in Veterans with PTSD and OSA. This feasibility study would form the
basis of a future trial examining the effectiveness of various therapeutic modalities for OSA
on PTSD symptomatology and progression.
performance and organ system dysfunction due to intermittent hypoxia and repeated arousals.
The repetitive hemodynamic stresses are implicated in the increased incidence of systemic
hypertension and cardiovascular diseases. Insufficient and disrupted sleep has similar
negative impact on mood, attention, cognition, and behavior. In Veterans with post traumatic
stress disorder (PTSD), the disturbed sleep can worsen further the cognitive-behavioral
manifestations of PTSD and contributes to poor mental and physical health outcomes. Recent
epidemiologic studies largely support the association of higher rates of OSA in patients with
PTSD compared with the general population. Treatment of the underlying obstructive sleep
disturbances with continuous positive airway pressure (CPAP) has resulted in restoration of
sleep architecture, decrease daytime sleepiness, and reduction in nightmares frequency and
intensity. However, adherence to treatment with CPAP is less than optimal in Veterans with
PTSD. Mandibular advancing devices (MADs) are considered non surgical alternatives to CPAP
and are preferred in a head to head comparison to CPAP in OSA subjects without PTSD. However,
there has been no study to the investigators' knowledge that has assessed MAD in terms of
clinical efficacy, compliance, and quality of sleep compared to CPAP in OSA patients with
PTSD. Therefore, the investigators hypothesize that MAD is not inferior to CPAP in treating
OSA effectively in Veterans with PTSD and OSA. To that end, the investigators propose to
conduct a feasibility study using a randomized crossover trial of 12 weeks of CPAP and MAD in
42 consecutive outpatients with PTSD newly diagnosed with OSA separated by 2 weeks washout
period.
The primary endpoint of the trial is to compare the treatment efficacy of CPAP and MAD in
Veterans with PTSD and OSA. Secondary endpoints aim at: 1) comparing change in the Epworth
Sleepiness Scale, SF-36, and the Pittsburgh Sleep Quality Index at end of treatment following
use of CPAP versus MAD, 2) comparing adherence and short-term side effects between using CPAP
and MAD in PTSD patients with OSA, and 3) determining anthropomorphic, polysomnographic, and
cephalometric predictors of successful MDA response. Assessments at the end of both limbs
comprise evaluation of quality of sleep, daytime sleepiness, quality of life, and side
effects of treatment. Compliance with each therapy will be measured at the end of each
treatment period.
The results of the trial are pivotal in determining the efficacy, tolerability, and adherence
to MAD compared to CPAP in Veterans with PTSD and OSA. This feasibility study would form the
basis of a future trial examining the effectiveness of various therapeutic modalities for OSA
on PTSD symptomatology and progression.
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
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