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

NCT ID: NCT01512771

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-08-31

Brief Summary

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).

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

Conditions

Post Traumatic Stress Disorder; Anxiety; Nightmares; Unrefreshed Sleep

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

CPAP

6 weeks of CPAP

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northport Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Mohammad M Amin

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Northport VAMC

Locations

PTSD unit at Northport VAMC

Northport, New York, United States

Countries

United States

Other Identifiers

00383

Identifier Type: -

Identifier Source: org_study_id