Effects of CPAP Therapy on PTSD Symptoms
|ClinicalTrials.gov Identifier: NCT02019914|
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : December 14, 2015
|Condition or disease|
|PTSD Sleep Obstructive Sleep Apnea Quality of Life|
Post traumatic stress disorder (PTSD) is associated with increased healthcare utilization, decreased functional status, and overall poor health. Sleep disturbances in PTSD are common, including nightmares, dream enactment, and poor sleep quality. Obstructive sleep apnea (OSA) is also highly prevalent in the veteran population and may exacerbate PTSD symptoms by triggering arousals from sleep that promote recollection of dreams, enactment of dreams, and disrupt sleep continuity. Improvements in sleep quality and PTSD symptoms have been reported when OSA is treated with continuous positive airway pressure (CPAP) therapy. However, formal assessment using validated questionnaires and documentation of CPAP compliance to correlate with these tools has not yet been performed. This study will recruit veterans with PTSD who have been newly diagnosed with OSA and who are willing to try CPAP therapy. Baseline assessments of PTSD symptoms, daytime sleepiness, sleep-related quality of life, sleep quality, general health perception, and mood will be performed before initiation of treatment and after 3 and 6 months of therapy.
This study will have the following specific aims:
Aim 1: To evaluate the effect of CPAP use on PTSD symptoms.
Hypothesis: After 6 months of treatment, CPAP use will improve PTSD symptoms as assessed by the PTSD checklist (PCL-S).
Aim 2: To evaluate the effect of CPAP use on 1)sleep quality and duration, 2)nocturnal symptoms of nightmares, movement disorders, dream enactment, and insomnia, 3)mood, 4)daytime sleepiness, 5)sleep-related quality of life, and 6) general health perception.
Hypothesis: After 6 months of treatment, CPAP use will improve sleep quality, sleep duration, mood, daytime sleepiness, sleep-related quality of life, general health perception, and nocturnal symptoms of nightmares, movement disorders, dream enactment, and insomnia.
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|Official Title:||Effects of Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnea on PTSD Symptoms|
|Study Start Date :||July 2013|
|Primary Completion Date :||June 2015|
|Study Completion Date :||June 2015|
PTSD and OSA
Veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and Obstructive Sleep Apnea (OSA), interested in a trial of CPAP therapy.
- Change in PTSD symptoms measured by the PTSD checklist (PCL-S). [ Time Frame: Baseline, 3 months, 6 months ]A change of -10 points on the PCL-S has been previously determined to be clinically significant.
- Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, 3 months, 6 months ]
- Sleep Related Quality of life with be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ-10). [ Time Frame: Baseline, 3 months, 6 months ]The FOSQ-10 consists of 10 questions, with a lower score indicating more difficulty with activity due to poor sleep.
- Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). [ Time Frame: Baseline, 3 months, 6 months ]This is a 19 item self-report assessment of sleep quality and degree of sleep difficulties over the past month. A global score>/=5 is considered poor sleep quality.
- Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). [ Time Frame: Baseline, 3 months, 6 months ]The PHQ-9 is a self report depression measure and is a quick, valid assessment of depression. Depression is a common comorbid condition with PTSD.
- General health related quality of life. [ Time Frame: Baseline, 3 months, 6 months ]This will be assessed using a likert scale question asking subjects to rate their quality of life for 2 preceding days based on spiritual, emotional, physical, social and financial aspects of their lives.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019914
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Kathleen F Sarmiento, MD||San Diego Veterans Healthcare System|