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The Effect of Nasal Continuous Positive Airway Pressure Treatment on PTSD Symptoms. (PTSD)

This study has been completed.
Information provided by (Responsible Party):
Mohammad M Amin, Northport Veterans Affairs Medical Center Identifier:
First received: January 13, 2012
Last updated: September 23, 2014
Last verified: September 2014
We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use alcohol to control their symptoms).

Condition Intervention
Post Traumatic Stress Disorder
Unrefreshed Sleep
Other: CPAP

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effect of Nasal Continuous Positive Airway Pressure (Nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.

Resource links provided by NLM:

Further study details as provided by Northport Veterans Affairs Medical Center:

Primary Outcome Measures:
  • The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms. [ Time Frame: six weeks of nasal CPAP ]
    A comparison of the effectiveness of six weeks of nasal CPAP plus usual care to usual care alone at decreasing the symptoms of PTSD (anxiety, insomnia and alcohol craving) among veterans with PTSD and SDB

Secondary Outcome Measures:
  • The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms. [ Time Frame: 6 weeks of nasal CPAP ]
    A comparison of the change in symptoms to the change in the total of sleep stage shifts during sleep for all patients with PTSD and SDB participating in the study.

Enrollment: 18
Study Start Date: March 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: CPAP
    6 weeks of CPAP
Detailed Description:

Design: This is a pilot study to study the effect of nasal CPAP on the symptoms of PTSD in veterans.

Recruitment Methods:

Veterans with PTSD will be recruited from the Northport VAMC PTSD unit. The ACOS/Mental Health will refer patients that meet inclusion criteria and do not have an impaired decision making capacity. Subjects will be screened for decision-making capacity by their treating psychiatrist as part of their clinical assessment upon admission to the PTSD unit.

Study Methods

This will be a prospective, randomized, controlled interventional trial:

  1. Participants will undergo a routine clinical sleep study at the PTSD unit (using a portable polysomnographic recording unit). or undergo a routine clinical polysomnography to diagnose sleep disordered breathing
  2. Participants who demonstrate SDB will be randomized into two groups based upon their body mass index

    1. Group A: BMI < 30 kg/m2
    2. Group B: BMI > 30 kg/m2 The reason for these two arms is to study the effect of nasal CPAP upon PTSD symptoms in veterans with a high prevalence of sleep apnea ( BMI above 30 kg/m2) and in veterans with predominantly snoring (BMI below 30 kg/m2).

    Each group will then be randomized into two sub-groups regarding treatment.

    1. Treatment group receives an automated CPAP unit to use during sleep for 6 weeks in conjunction with their usual care in the PTSD unit (psychotherapy).
    2. Control group receives the usual care that is provided in the PTSD unit for 6 weeks (change in medications will exclude the subject from the study), if any participant in the control group would like to try nasal CPAP, then he will be crossed over to use an automated CPAP unit during sleep for his second 6 weeks in the PTSD unit together with usual care.
  3. All participants will fill out the following questionnaires at baseline and after 6 weeks. (Those in the control group who have been crossed-over to nasal CPAP will also fill out a set of questionnaire at 12 weeks).

    1. PTSD checklist-military version (anxiety)
    2. MASQ anxious arousal subscale (anxiety)
    3. Insomnia Severity Index (insomnia)
    4. The alcohol craving questionnaire (with an alcohol history during the intake) The changes in patient's reported outcomes will be compared before and after CPAP treatment and psychotherapy alone

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
veterans admitted to PTSD unit at Northport VAMC

Inclusion Criteria:

A. Admitted to PTSD unit at NVAMC and will remain in the unit for at least 12 weeks after initiation of study participation.

B. Found to have SDB by polysomnography

Exclusion Criteria:

  1. Impaired Decision-Making Capacity, as determined by treating psychiatrist.
  2. No sleep disordered breathing found by polysomnography
  3. Unable/unwilling to use the nasal CPAP
  Contacts and Locations
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Please refer to this study by its identifier: NCT01512771

United States, New York
PTSD unit at Northport VAMC
Northport, New York, United States, 11768
Sponsors and Collaborators
Northport Veterans Affairs Medical Center
Principal Investigator: Mohammad Amin, MD Northport VAMC
  More Information

Responsible Party: Mohammad M Amin, Staff Physician, Northport Veterans Affairs Medical Center Identifier: NCT01512771     History of Changes
Other Study ID Numbers: 00383
Study First Received: January 13, 2012
Last Updated: September 23, 2014

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders processed this record on May 25, 2017