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Completed

NCT Number: NCT02019914

Effects of CPAP Therapy 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.

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Key information

Conditions

PTSD Apnea Dyssomnias Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Quality of Life Respiration Disorders Respiratory Tract Diseases Sleep Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS)

    Time frame: Baseline, 3 months, 6 months

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2013
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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