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Clinical Trials/NCT01512771
NCT01512771CompletedNot Applicable

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

Northport Veterans Affairs Medical Center1 site in 1 country18 target enrollmentStarted: March 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
18
Locations
1
Primary Endpoint
The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.

Study Overview

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:

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Impaired Decision-Making Capacity, as determined by treating psychiatrist.
  • No sleep disordered breathing found by polysomnography
  • Unable/unwilling to use the nasal CPAP

Outcomes

Primary Outcomes

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 Outcomes

  • The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.(6 weeks of nasal CPAP)

Investigators

Sponsor
Northport Veterans Affairs Medical Center
Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Mohammad M Amin

Staff Physician

Northport Veterans Affairs Medical Center

Study Sites (1)

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