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

Anxiety Clinical Trial

— PTSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512771
• Other study ID #: 00383
• Status: Completed
• Phase: N/A
• First received: January 13, 2012
• Last updated: September 23, 2014
• Start date: March 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Northport Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Nightmares
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Unrefreshed Sleep

Intervention

Other:
• CPAP
6 weeks of CPAP

Locations

Country	Name	City	State
United States	PTSD unit at Northport VAMC	Northport	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northport Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.	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	six weeks of nasal CPAP	No
Secondary	The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.	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.	6 weeks of nasal CPAP	No