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Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)

NCT03039231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-03-25

No results posted yet for this study

Summary

This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD).

Conditions

  • Stress Disorders, Post-Traumatic

Interventions

DEVICE

Freespira Breathing System

Following authorization from a study team member, patient will be assigned an FBS to take home and perform 4 weeks of training exercises twice a day for 17 minutes each time. Efficacy of the FBS system will be evaluate over the 4 week period and at 2 and 6 month follow-up periods.

Sponsors & Collaborators

  • VA Palo Alto Health Care System

    collaborator FED

  • Palo Alto Health Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael J Ostacher, MD · VA Palo Alto Health Care System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-04-24
Completion
2019-08-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03039231 on ClinicalTrials.gov