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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Northport Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Mohammad M Amin, Northport Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01512771
First received: January 13, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

Hypothesis #1. We hypothesize that prevention of SDB among PTSD patients with nasal CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use alcohol to control their symptoms).

Hypothesis #2. We hypothesize that the change in symptoms among the PTSD patients participating in the study will be paralleled by a change in the total of sleep stage shifts observed during polysomnography.


Condition Intervention
PTSD Symptoms
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2
Study Start Date: March 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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).
  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). This distinction is important because in Dr Amin's GWI research, reviewers argued that the nasal CPAP was not having a specific effect on GWI, but treating sleep apnea in GWI patients resulting in nonspecific improvement in GWI symptoms.

    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) All participants will undergo portable polysomnography with their assigned treatment at baseline and at the end of 6 weeks of their participation. All those in the control group who cross-over to nasal CPAP will also undergo portable polysomnography at 12 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

veterans admitted to PTSD unit at Northport VAMC

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512771

Contacts
Contact: Mohammad M Amin, MD 631 261 4400 ext 2469 mohammad.amin2@va.gov

Locations
United States, New York
PTSD unit at Northport VAMC Recruiting
Northport, New York, United States, 11768
Contact: Dorothy Baker    631-261-4400 ext 2850    Dorothy.Baker3@va.gov   
Sponsors and Collaborators
Northport Veterans Affairs Medical Center
Investigators
Principal Investigator: Mohammad Amin, MD Northport VAMC
  More Information

No publications provided

Responsible Party: Mohammad M Amin, Staff Physician, Northport Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01512771     History of Changes
Other Study ID Numbers: 00383
Study First Received: January 13, 2012
Last Updated: January 13, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014