Pain, ChronicNCT05791435
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
A study testing PneuRIP and biofeedback to assist with breathing in people with Pain, Chronic, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
This project will develop and test a wearable breathing monitor that will measure the synchrony in breathing between the diaphragm and chest of children with a pain diagnosis while receiving yoga therapy. Specifically, we will develop a biofeedback system to help improve breathing in pain patients. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- PneuRIP and biofeedback to assist with breathing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 29 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth with Chronic pain Prescribed yoga therapy as part of treatment plan
Who cannot join
- Otherwise healthy
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware, 19899
About this study
This project will develop and test a wearable breathing monitor that will measure the synchrony in breathing between the diaphragm and chest of children with a pain diagnosis while receiving yoga therapy. Specifically, we will develop a biofeedback system to help improve breathing in pain patients.
Read the detailed description
This Small Business Technology Transfer (STTR) Phase I application proposes the development and trial of a novel non-invasive real-time breathing sensor - pneuRIP- to show the beneficial effects of respiratory biofeedback on yoga. PneuRIP will be employed to monitor and improve asana (posture) and pranayama (breathing) in yoga in youth with chronic pain. The sensor consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. Measures include the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.
The first part of the proposal will develop the biofeedback software. The biofeedback component will be related to the synchrony between diaphragmatic and chest breathing, and the relative depth of breathing. This information will be presented to the user visually on an iPad screen in the form of 2 moving bars - one corresponding to the chest and one to the belly.
In the second part of the study, we will test the pneuRIP with biofeedback with 20 youth with pain enrolled in an interdisciplinary pediatric chronic pain program in a large pediatric hospital receiving yoga as one of the therapies. The yoga regimen is 8 sessions, once per week. Subjects will be randomized into two groups: one receiving instruction only on synchronous breathing; the second group will receive biofeedback in addition. Outcome will phase angle between abdomen and ribcage (recorded during each session). Outcomes will inform the feasibility of using real-time biofeedback in yoga with a non-invasive respiratory monitor.
- Conditions
- Pain, Chronic
- Being tested
- PneuRIP, biofeedback to assist with breathing
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneuRIPDevice
Also called Non-invasive breathing monitor
Measuring respiratory indices through Respiratory Inductance Plethysmography
biofeedback to assist with breathingOther
Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback group | Experimental | This group will receive biofeedback to assist with breathing Receives: Device: PneuRIP; Other: biofeedback to assist with breathing |
| Non-Biofeedback group | Experimental | This group will only have their breathing monitored after instruction Receives: Device: PneuRIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Angle
Measures synchrony between chest and stomach. The phase angle is measured in degrees. If the chest and stomach move together then the phase angle is zero degrees. If they were to move in opposite directions the phase angle would be 180 degrees.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 May 2023
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tariq Rahman, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791435
- Sponsor's protocol ID
- 1904079
- Other IDs
- 3R41AT012155-01S1
- Status last verified
- Jan 2025
- First submitted
- 17 Mar 2023
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
- ClinicalTrials.gov ID
- NCT05791435
- Acronym / sponsor ID
- 1904079
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will develop and test a wearable breathing monitor that will measure the synchrony in breathing between the diaphragm and chest of children with a pain diagnosis while receiving yoga therapy. Specifically, we will develop a biofeedback system to help improve breathing in pain patients.
Detailed description
This Small Business Technology Transfer (STTR) Phase I application proposes the development and trial of a novel non-invasive real-time breathing sensor - pneuRIP- to show the beneficial effects of respiratory biofeedback on yoga. PneuRIP will be employed to monitor and improve asana (posture) and pranayama (breathing) in yoga in youth with chronic pain. The sensor consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. Measures include the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.
The first part of the proposal will develop the biofeedback software. The biofeedback component will be related to the synchrony between diaphragmatic and chest breathing, and the relative depth of breathing. This information will be presented to the user visually on an iPad screen in the form of 2 moving bars - one corresponding to the chest and one to the belly.
In the second part of the study, we will test the pneuRIP with biofeedback with 20 youth with pain enrolled in an interdisciplinary pediatric chronic pain program in a large pediatric hospital receiving yoga as one of the therapies. The yoga regimen is 8 sessions, once per week. Subjects will be randomized into two groups: one receiving instruction only on synchronous breathing; the second group will receive biofeedback in addition. Outcome will phase angle between abdomen and ribcage (recorded during each session). Outcomes will inform the feasibility of using real-time biofeedback in yoga with a non-invasive respiratory monitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback group | Experimental | Device: PneuRIP, Other: biofeedback to assist with breathingThis group will receive biofeedback to assist with breathing |
| Non-Biofeedback group | Experimental | Device: PneuRIPThis group will only have their breathing monitored after instruction |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Youth with Chronic pain Prescribed yoga therapy as part of treatment plan
Key exclusion criteria (1 listed)
- Otherwise healthy
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 |
|---|---|---|
| PneuRIPAlso: Non-invasive breathing monitorMeasuring respiratory indices through Respiratory Inductance Plethysmography | Device | Biofeedback group, Non-Biofeedback group |
| biofeedback to assist with breathingMeasuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen | Other | Biofeedback group |
Primary outcome
Phase Angle
Time frame: 8 weeks
Measures synchrony between chest and stomach. The phase angle is measured in degrees. If the chest and stomach move together then the phase angle is zero degrees. If they were to move in opposite directions the phase angle would be 180 degrees.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PneuRIP and biofeedback to assist with breathing in people with Pain, Chronic, run by Nemours Children's Clinic 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase Angle (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 13 Jan 2025.