PTSDNCT02019914
Effects of CPAP Therapy on PTSD Symptoms
An observational study of PTSD and Sleep, run by Veterans Medical Research Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Sleep, Obstructive Sleep Apnea
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with confirmed diagnoses of PTSD and OSA who are willing to try CPAP therapy.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: 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.
Read the 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.
- Conditions
- PTSD, Sleep, Obstructive Sleep Apnea, Quality of Life
- Keywords
- PTSD, CPAP, OSA
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Kathleen F Sarmiento, MD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019914
- Sponsor's protocol ID
- H130095
- Status last verified
- Dec 2015
- First submitted
- 18 Dec 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18629744Kubzansky 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.
PubMed 17199060Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
PubMed 15229303Hoge 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.
PubMed 17202557Kulka 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.
Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
PubMed 15939837Kang HK, Natelson BH, Mahan CM, Lee KY, Murphy FM. Post-traumatic stress disorder and chronic fatigue syndrome-like illness among Gulf War veterans: a population-based survey of 30,000 veterans. Am J Epidemiol. 2003 Jan 15;157(2):141-8. doi: 10.1093/aje/kwf187.
PubMed 12522021El-Sherbini AM, Bediwy AS, El-Mitwalli A. Association between obstructive sleep apnea (OSA) and depression and the effect of continuous positive airway pressure (CPAP) treatment. Neuropsychiatr Dis Treat. 2011;7:715-21. doi: 10.2147/NDT.S26341. Epub 2011 Dec 13.
PubMed 22247613Belleville G, Guay S, Marchand A. Impact of sleep disturbances on PTSD symptoms and perceived health. J Nerv Ment Dis. 2009 Feb;197(2):126-32. doi: 10.1097/NMD.0b013e3181961d8e.
PubMed 19214048Yesavage JA, Kinoshita LM, Kimball T, Zeitzer J, Friedman L, Noda A, David R, Hernandez B, Lee T, Cheng J, O'hara R. Sleep-disordered breathing in Vietnam veterans with posttraumatic stress disorder. Am J Geriatr Psychiatry. 2012 Mar;20(3):199-204. doi: 10.1097/JGP.0b013e3181e446ea.
PubMed 20808112Krakow B, Melendrez D, Johnston L, Warner TD, Clark JO, Pacheco M, Pedersen B, Koss M, Hollifield M, Schrader R. Sleep-disordered breathing, psychiatric distress, and quality of life impairment in sexual assault survivors. J Nerv Ment Dis. 2002 Jul;190(7):442-52. doi: 10.1097/00005053-200207000-00004.
PubMed 12142845Krakow B, Lowry C, Germain A, Gaddy L, Hollifield M, Koss M, Tandberg D, Johnston L, Melendrez D. A retrospective study on improvements in nightmares and post-traumatic stress disorder following treatment for co-morbid sleep-disordered breathing. J Psychosom Res. 2000 Nov;49(5):291-8. doi: 10.1016/s0022-3999(00)00147-1.
PubMed 11164053Webber MP, Lee R, Soo J, Gustave J, Hall CB, Kelly K, Prezant D. Prevalence and incidence of high risk for obstructive sleep apnea in World Trade Center-exposed rescue/recovery workers. Sleep Breath. 2011 Sep;15(3):283-94. doi: 10.1007/s11325-010-0379-7. Epub 2010 Jul 1.
PubMed 20593281van Liempt S, Westenberg HG, Arends J, Vermetten E. Obstructive sleep apnea in combat-related posttraumatic stress disorder: a controlled polysomnography study. Eur J Psychotraumatol. 2011;2. doi: 10.3402/ejpt.v2i0.8451. Epub 2011 Dec 26.
PubMed 22893807Kinoshita 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.
PubMed 22193972
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnea on PTSD Symptoms
- ClinicalTrials.gov ID
- NCT02019914
- Acronym / sponsor ID
- H130095
- Conditions
- PTSD, Sleep, Obstructive Sleep Apnea, Quality of Life
- Keywords
- PTSD, CPAP, OSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTSD and OSA | – | –Veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and Obstructive Sleep Apnea (OSA), interested in a trial of CPAP therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with confirmed diagnoses of PTSD and OSA who are willing to try CPAP therapy.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS)
Time frame: 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
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Baseline, 3 months, 6 months
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
Time frame: Baseline, 3 months, 6 months
General health related quality of life.
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Background: PubMed 18629744Vasterling 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.
- Background: PubMed 17199060Kubzansky 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.
- Background: PubMed 15229303Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
- Background: PubMed 17202557Hoge 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.
- BackgroundKulka 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.
- Background: PubMed 15939837Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
- Background: PubMed 12522021Kang HK, Natelson BH, Mahan CM, Lee KY, Murphy FM. Post-traumatic stress disorder and chronic fatigue syndrome-like illness among Gulf War veterans: a population-based survey of 30,000 veterans. Am J Epidemiol. 2003 Jan 15;157(2):141-8. doi: 10.1093/aje/kwf187.
- Background: PubMed 22247613El-Sherbini AM, Bediwy AS, El-Mitwalli A. Association between obstructive sleep apnea (OSA) and depression and the effect of continuous positive airway pressure (CPAP) treatment. Neuropsychiatr Dis Treat. 2011;7:715-21. doi: 10.2147/NDT.S26341. Epub 2011 Dec 13.
- Background: PubMed 19214048Belleville G, Guay S, Marchand A. Impact of sleep disturbances on PTSD symptoms and perceived health. J Nerv Ment Dis. 2009 Feb;197(2):126-32. doi: 10.1097/NMD.0b013e3181961d8e.
- Background: PubMed 20808112Yesavage JA, Kinoshita LM, Kimball T, Zeitzer J, Friedman L, Noda A, David R, Hernandez B, Lee T, Cheng J, O'hara R. Sleep-disordered breathing in Vietnam veterans with posttraumatic stress disorder. Am J Geriatr Psychiatry. 2012 Mar;20(3):199-204. doi: 10.1097/JGP.0b013e3181e446ea.
- Background: PubMed 12142845Krakow B, Melendrez D, Johnston L, Warner TD, Clark JO, Pacheco M, Pedersen B, Koss M, Hollifield M, Schrader R. Sleep-disordered breathing, psychiatric distress, and quality of life impairment in sexual assault survivors. J Nerv Ment Dis. 2002 Jul;190(7):442-52. doi: 10.1097/00005053-200207000-00004.
- Background: PubMed 11164053Krakow B, Lowry C, Germain A, Gaddy L, Hollifield M, Koss M, Tandberg D, Johnston L, Melendrez D. A retrospective study on improvements in nightmares and post-traumatic stress disorder following treatment for co-morbid sleep-disordered breathing. J Psychosom Res. 2000 Nov;49(5):291-8. doi: 10.1016/s0022-3999(00)00147-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen F Sarmiento, MD principal investigator
San Diego Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Sleep, run by Veterans Medical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms measured by the PTSD checklist (PCL-S). (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019914, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.