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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 80
Updated:11/8/2014
Start Date:March 2010
End Date:January 2015
Contact:Mohammad M Amin, MD
Email:mohammad.amin2@va.gov
Phone:631 261 4400

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The Effect of Nasal Continuous Positive Airway Pressure (Nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.

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.

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.

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
We found this trial at
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Northport, New York 11768
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Northport, NY
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