Effects of CPAP Therapy on PTSD Symptoms

December 10, 2015 updated by: Veterans Medical Research Foundation

Effects of Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnea on PTSD Symptoms

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PTSD and OSA
Veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and Obstructive Sleep Apnea (OSA), interested in a trial of CPAP therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Medical Research Foundation

Collaborators

American Academy of Sleep Medicine

Investigators

  • Principal Investigator: Kathleen F Sarmiento, MD, San Diego Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H130095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PTSD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe