Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Outcomes will be standardized measures of pain (recorded before and after entire regimen) and breathing indices (recorded during each session). Outcomes will inform the feasibility of using real-time biofeedback in yoga with a non-invasive respiratory monitor.

Official Title
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Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.

Conditions
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Pain, Chronic

Intervention / Treatment
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* Device: PneuRIP
* Other: biofeedback to assist with breathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Youth with Chronic pain Prescribed yoga therapy as part of treatment plan Exclusion Criteria: Otherwise healthy

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback group<br>This group will receive biofeedback to assist with breathing | Device: PneuRIP<br>* Measuring respiratory indices through Respiratory Inductance Plethysmography<br>* Other names: Non-invasive breathing monitor;Other: biofeedback to assist with breathing<br>* Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen<br>|
| Experimental: Non-Biofeedback group<br>This group will only have their breathing monitored after instruction | Device: PneuRIP<br>* Measuring respiratory indices through Respiratory Inductance Plethysmography<br>* Other names: Non-invasive breathing monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase angle | Measures synchrony between chest and stomach | 8 weeks |