AnxietyNCT02998502
The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens
A study testing Freespira Breathing System in people with Anxiety and Panic Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will test the efficiency of the Freespira Breathing System in youth. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Anxiety, Panic Disorder
- What is being tested?
- Freespira Breathing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
- There is an active condition of asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders
This study will test the efficiency of the Freespira Breathing System in youth.
Read the detailed description
The Freespira Breathing System (FBS; www.freespira.com) 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 now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or lower acceptability for long-term medication use for adolescent PD.
In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In children adolescents, PD itself is less common than in adults, but when present, PD is commonly associated with and/or preceded by other anxiety conditions, including generalized anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children and adolescents, the breathing biofeedback intervention for panic, should include other anxiety disorders.
- Conditions
- Anxiety, Panic Disorder
- Being tested
- Freespira Breathing System
- Keywords
- Obsessive Compulsive Disorder (OCD), Anxiety, Pediatrics
- Medical subject headings
- Anxiety Disorders, Panic Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freespira Breathing SystemDevice
Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.
| Study group | Role | What they receive |
|---|---|---|
| Device Group | Experimental | The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested. Receives: Device: Freespira Breathing System |
| Control Group | No intervention | The device will be given to those in the control group after 8-week baseline period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen for Child Anxiety Related Disorders (SCARED) scale score
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Measured: 8-weeks
Secondary outcomes (19)
SCARED anxiety scale score
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Measured: Baseline
SCARED anxiety scale score
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Measured: Week 4 Follow Up
SCARED anxiety scale score
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Measured: Week 8 Follow Up
SCARED anxiety scale score
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Measured: 6-month Follow Up
SCARED anxiety scale score
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Measured: 12-month Follow Up
End-tidal carbon dioxide (CO2)
End-tidal CO2 at 4 weeks Measured using Freespira breathing system 4 minutes breathing session Parameters number of millimeters per mercury.
Measured: 4 weeks
Respiratory rate level
Respiratory rate at 4 weeks Measured using Freespira breathing system 4 minutes breathing session. The parameters are number of breaths per minute.
Measured: 4 weeks
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
Measured: Baseline
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
Measured: Week 4 Follow Up
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
Measured: Week 8 Follow Up
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
Measured: 6-Month Follow Up
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
Measured: 12 month Follow Up
Clinician's Global Impression scale.
Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
Measured: Baseline
Clinician's Global Impression scale.
Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
Measured: Week 4 Follow Up
Clinician's Global Impression scale.
Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
Measured: Week 8 Follow Up
Child Yale Brown Obsessive-Compulsive Scale score
Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
Measured: Baseline
Child Yale Brown Obsessive-Compulsive Scale score
Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
Measured: Week 4 Follow Up
Child Yale Brown Obsessive-Compulsive Scale score
Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
Measured: Week 8 Follow Up
Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)
Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Sep 2016
- Primary completion5 Dec 2019
- Study completion30 Jan 2021
Why it stopped: minimum subject accrual complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Alto Health Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Marco Grados, M.D., M.P.H., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998502
- Sponsor's protocol ID
- IRB00097094
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2016
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders
- ClinicalTrials.gov ID
- NCT02998502
- Acronym / sponsor ID
- IRB00097094
- Conditions
- Anxiety, Panic Disorder
- Keywords
- Obsessive Compulsive Disorder (OCD), Anxiety, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: minimum subject accrual complete
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Palo Alto Health Sciences, Inc.
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the efficiency of the Freespira Breathing System in youth.
Detailed description
The Freespira Breathing System (FBS; www.freespira.com) 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 now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or lower acceptability for long-term medication use for adolescent PD.
In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In children adolescents, PD itself is less common than in adults, but when present, PD is commonly associated with and/or preceded by other anxiety conditions, including generalized anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children and adolescents, the breathing biofeedback intervention for panic, should include other anxiety disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Group | Experimental | Device: Freespira Breathing SystemThe Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested. |
| Control Group | No intervention | –The device will be given to those in the control group after 8-week baseline period. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- There is an active condition of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freespira Breathing SystemOver an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline. | Device | Device Group |
Primary outcome
Screen for Child Anxiety Related Disorders (SCARED) scale score
Time frame: 8-weeks
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
19 secondary outcomes
SCARED anxiety scale score
Time frame: Baseline
SCARED anxiety scale score
Time frame: Week 4 Follow Up
SCARED anxiety scale score
Time frame: Week 8 Follow Up
SCARED anxiety scale score
Time frame: 6-month Follow Up
SCARED anxiety scale score
Time frame: 12-month Follow Up
End-tidal carbon dioxide (CO2)
Time frame: 4 weeks
Respiratory rate level
Time frame: 4 weeks
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Time frame: Baseline
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Time frame: Week 4 Follow Up
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Time frame: Week 8 Follow Up
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Time frame: 6-Month Follow Up
Panic Disorder Severity Scale for Adolescents (PDSS-A)
Time frame: 12 month Follow Up
Clinician's Global Impression scale.
Time frame: Baseline
Clinician's Global Impression scale.
Time frame: Week 4 Follow Up
Clinician's Global Impression scale.
Time frame: Week 8 Follow Up
Child Yale Brown Obsessive-Compulsive Scale score
Time frame: Baseline
Child Yale Brown Obsessive-Compulsive Scale score
Time frame: Week 4 Follow Up
Child Yale Brown Obsessive-Compulsive Scale score
Time frame: Week 8 Follow Up
Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)
Time frame: Week 8
Results and safety
The study was stopped early (reason given: minimum subject accrual complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Grados, M.D., M.P.H. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freespira Breathing System in people with Anxiety and Panic Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: minimum subject accrual complete). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen for Child Anxiety Related Disorders (SCARED) scale score (time frame: 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.