Effects of CPAP Therapy on PTSD Symptoms

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019914
• Other study ID #: H130095
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: December 10, 2015
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• PTSD
• Quality of Life
• Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS)		Baseline, 3 months, 6 months	No
Secondary	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.	Baseline, 3 months, 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No