A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT01569022|
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: CPAP Device: MAD||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||randomized trial|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Cross Over Trial of Two Treatments for OSA in Veterans With PTSD|
|Actual Study Start Date :||November 1, 2012|
|Actual Primary Completion Date :||October 30, 2016|
|Actual Study Completion Date :||March 30, 2017|
Active Comparator: CPAP First, MAD
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks
CPAP Treatment for 12 weeks
MAD Treatment for 12 weeks
Experimental: MAD First, CPAP
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks
CPAP Treatment for 12 weeks
MAD Treatment for 12 weeks
- Residual Apnea Hypopnea Index [ Time Frame: up to 12 weeks ]The primary endpoint of the study was tested by comparing the upper limit of the 95% confidence interval for the CPAP-MAD difference in residual AHI with the a priori noninferiority margin using the paired t test
- Health Outcomes [ Time Frame: 12 weeks ]Health outcomes including ESS, PCL-M, and PSQI. ESS is a short questionnaire validated to measure excessive daytime sleepiness in patients with OSA 17. It measures the likelihood of falling asleep in eight different situations, with a score of 0-3 for each situation. The sum of individual scores for the eight items gives the final ESS score, ranging from 0-21. An ESS score >10 suggests excessive daytime sleepiness (EDS). The PSQI is a self-rating questionnaire that consists of seven dimensions. The possible scores range from 0-21, with greater than five indicative of impaired sleep quality. The PTSD Checklist is a 17-item self-report measure (1-5 points each) that assesses PTSD symptoms in relation to stressful military experiences. PTSD symptom severity scores are determined by summing the participants' answers to all 17 items from 1 ("not at all") to 5 ("extremely")(range 17-85) 14 with 5-10 point change indicating statistically significant response to treatment
- General Health SF-36 [ Time Frame: 12 weeks ]The SF-36 is a generic 36-item Short Form Medical Outcomes Survey (SF-36) 16. It has eight main domains: physical functioning, role limitation due to physical problems, role limitation due to emotional problems, social functioning, mental health, energy/vitality, bodily pain, and general health perception. General Health SF36 score is coded, summed, and transformed onto a scale from 0 to 100 (worst to best possible health).
- Adherence to Therapy [ Time Frame: 12 weeks ]comparison of the number of hours per night used while on CPAP versus MAD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569022
|United States, New York|
|VA Western New York Healthcare System, Buffalo, NY|
|Buffalo, New York, United States, 14215|
|Principal Investigator:||Ali A El-Solh, MD MPH||VA Western New York Healthcare System, Buffalo, NY|