The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorJohns Hopkins University
About this trial
This study will test the efficiency of the Freespira Breathing System in youth.
Eligibility criteria
Qualifiers
SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder
Participants must be 9-17 years of age
If on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment
Disqualifiers
Anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease
Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study
Currently undergoing breathing biofeedback elsewhere
Demonstrate evidence of severe suicidal ideation or psychosis
Trial design
Treatments tested in this trial
- Freespira Breathing System
Treatment groups
73 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Palo Alto Health Sciences, Inc.
Collaborator
Source ClinicalTrials.gov