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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours/A.I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Youth with Chronic pain Prescribed yoga therapy as part of treatment plan

Exclusion criteria

Otherwise healthy

Treatment and study plan

pneuRIP

Device

Measuring respiratory indices through Respiratory Inductance Plethysmography

Other names: Non-invasive breathing monitor

biofeedback to assist with breathing

Other

Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Mar 30, 2023
Registry last updated: Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed