NCT01512771

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4.4 years

First QC Date

January 13, 2012

Last Update Submit

September 23, 2014

Conditions

Post Traumatic Stress DisorderAnxietyNightmaresUnrefreshed Sleep

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    6 weeks of nasal CPAP

Interventions

CPAPOTHER

6 weeks of CPAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

veterans admitted to PTSD unit at Northport VAMC

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PTSD unit at Northport VAMC

Northport, New York, 11768, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Mohammad Amin, MD

    Northport VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

March 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

US(1)