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| ID | Type | Description | Link |
|---|---|---|---|
| 3R41AT012155-01S1 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback group | Experimental | This group will receive biofeedback to assist with breathing |
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| Non-Biofeedback group | Experimental | This group will only have their breathing monitored after instruction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PneuRIP | Device | Measuring respiratory indices through Respiratory Inductance Plethysmography |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours/A.I. duPont Hospital for Children | Wilmington | Delaware | 19899 | United States |
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Recruited in Medical clinic. Dates are 5/1/23-8/29/23
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| ID | Title | Description |
|---|---|---|
| FG000 | Biofeedback Group | This group will receive biofeedback to assist with breathing PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography biofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen |
| FG001 | Non-Biofeedback Group | This group will only have their breathing monitored after instruction PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofeedback Group | This group will receive biofeedback to assist with breathing PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography biofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | degrees | 8 weeks |
|
4 months
The risk for serious adverse events, non-serious adverse events and all-cause mortality is zero as the study monitored subjects' breathing while performing routine therapy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biofeedback Group | This group will receive biofeedback to assist with breathing PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography biofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tariq Rahman | Nemours Children Health System | 302 651 6831 | trahman@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2022 | Dec 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2022 | Dec 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012119 | Respiration |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| biofeedback to assist with breathing | Other | Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen |
|
| BG001 |
| Non-Biofeedback Group |
This group will only have their breathing monitored after instruction PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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This group will only have their breathing monitored after instruction
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Non-Biofeedback Group | This group will only have their breathing monitored after instruction PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography | 0 | 7 | 0 | 7 | 0 | 7 |
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