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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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The purpose of this study is to evaluate the effects of treating Obstructive Sleep Apnea (OSA) with continuous positive airway pressure (CPAP) therapy on symptoms of post traumatic stress disorder (PTSD). The study hypotheses are that CPAP use will improve PTSD symptoms overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms related to PTSD, mood, daytime sleepiness, sleep-related quality of life, and general health perception.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD and OSA | Veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and Obstructive Sleep Apnea (OSA), interested in a trial of CPAP therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms measured by the PTSD checklist (PCL-S). | A change of -10 points on the PCL-S has been previously determined to be clinically significant. | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS) | Baseline, 3 months, 6 months | |
| Sleep Related Quality of life with be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ-10). | The FOSQ-10 consists of 10 questions, with a lower score indicating more difficulty with activity due to poor sleep. |
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Inclusion Criteria:The intent is to recruit a study population that is as representative as possible of the veteran PTSD population. Thus, entry criteria are as inclusive as possible:
Exclusion Criteria:
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Veterans with confirmed diagnoses of PTSD and OSA who are willing to try CPAP therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen F Sarmiento, MD | San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18629744 | Background | Vasterling JJ, Schumm J, Proctor SP, Gentry E, King DW, King LA. Posttraumatic stress disorder and health functioning in a non-treatment-seeking sample of Iraq war veterans: a prospective analysis. J Rehabil Res Dev. 2008;45(3):347-58. doi: 10.1682/jrrd.2007.05.0077. | |
| 17199060 | Background | Kubzansky LD, Koenen KC, Spiro A 3rd, Vokonas PS, Sparrow D. Prospective study of posttraumatic stress disorder symptoms and coronary heart disease in the Normative Aging Study. Arch Gen Psychiatry. 2007 Jan;64(1):109-16. doi: 10.1001/archpsyc.64.1.109. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
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| Baseline, 3 months, 6 months |
| Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). | 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. | Baseline, 3 months, 6 months |
| Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). | 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. | Baseline, 3 months, 6 months |
| General health related quality of life. | 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. | Baseline, 3 months, 6 months |
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| 17202557 | Background | Hoge CW, Terhakopian A, Castro CA, Messer SC, Engel CC. Association of posttraumatic stress disorder with somatic symptoms, health care visits, and absenteeism among Iraq war veterans. Am J Psychiatry. 2007 Jan;164(1):150-3. doi: 10.1176/ajp.2007.164.1.150. |
| Background | Kulka RA, Schlenger WA, Fairbanks JA, et al. Trauma and the Vietnam War generation: report of findings from the National Vietnam Veterans Readjustment Study (1990). New York: Brunner/Mazel. |
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| 22193972 | Background | Kinoshita LM, Yesavage JA, Noda A, Jo B, Hernandez B, Taylor J, Zeitzer JM, Friedman L, Fairchild JK, Cheng J, Kuschner W, O'Hara R, Holty JE, Scanlon BK. Modeling the effects of obstructive sleep apnea and hypertension in Vietnam veterans with PTSD. Sleep Breath. 2012 Dec;16(4):1201-9. doi: 10.1007/s11325-011-0632-8. Epub 2011 Dec 23. |
| 21530936 | Background | Ahmadi N, Hajsadeghi F, Mirshkarlo HB, Budoff M, Yehuda R, Ebrahimi R. Post-traumatic stress disorder, coronary atherosclerosis, and mortality. Am J Cardiol. 2011 Jul 1;108(1):29-33. doi: 10.1016/j.amjcard.2011.02.340. Epub 2011 Apr 29. |
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| Background | Weathers F, Litz B, Herman D, et al. (October 1993). The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX. |
| 17591505 | Background | Yeager DE, Magruder KM, Knapp RG, Nicholas JS, Frueh BC. Performance characteristics of the posttraumatic stress disorder checklist and SPAN in Veterans Affairs primary care settings. Gen Hosp Psychiatry. 2007 Jul-Aug;29(4):294-301. doi: 10.1016/j.genhosppsych.2007.03.004. |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
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| 27707436 | Derived | Orr JE, Smales C, Alexander TH, Stepnowsky C, Pillar G, Malhotra A, Sarmiento KF. Treatment of OSA with CPAP Is Associated with Improvement in PTSD Symptoms among Veterans. J Clin Sleep Med. 2017 Jan 15;13(1):57-63. doi: 10.5664/jcsm.6388. |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |