Effects of CPAP Therapy on PTSD Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Veterans Medical Research Foundation
Sponsor:
Collaborator:
American Academy of Sleep Medicine
Information provided by (Responsible Party):
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT02019914
First received: December 18, 2013
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition
PTSD
Sleep
Obstructive Sleep Apnea
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnea on PTSD Symptoms

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Change in PTSD symptoms measured by the PTSD checklist (PCL-S). [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    A change of -10 points on the PCL-S has been previously determined to be clinically significant.


Secondary Outcome Measures:
  • Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Sleep Related Quality of life with be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ-10). [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
PTSD and OSA
Veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and Obstructive Sleep Apnea (OSA), interested in a trial of CPAP therapy.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Veterans with confirmed diagnoses of PTSD and OSA who are willing to try CPAP therapy.

Criteria

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:

  • age >18 year
  • confirmed diagnosis of PTSD (PCL checklist minimum score of 45)
  • confirmed diagnosis of sleep apnea (apnea hypopnea index >5/h)
  • newly starting CPAP (not previously treated)

Exclusion Criteria:

  • fatal co-morbidity with life expectancy of less than 6 months,
  • residing in a geographically remote area that would make follow up at 3 and 6 months difficult.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019914

Contacts
Contact: Carolina Smales, BS 858-522-8585 ext 2795 carolina.smales@va.gov

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Carolina Smales       carolina.smales@va.gov   
Sponsors and Collaborators
Veterans Medical Research Foundation
American Academy of Sleep Medicine
Investigators
Principal Investigator: Kathleen F Sarmiento, MD San Diego Veterans Healthcare System
  More Information

Publications:
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.

Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02019914     History of Changes
Other Study ID Numbers: H130095
Study First Received: December 18, 2013
Last Updated: September 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
PTSD
CPAP
OSA

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014