NCT03039231

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

Investigation of the Freespira Breathing System in the Treatment of PTSD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Palo Alto Health Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (PD). The FBS has received FDA clearance for the treatment of PD adults and is currently commercially available. This study is a prospective, single arm, un-blinded investigation of the Freespira Breathing System in the PTSD population.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-04-24
• Completion: 2019-08-25
• First posted: 2017-02-01
• Last updated: 2020-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study