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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05791435
• Other study ID #: 1904079
• Status: Completed
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Otherwise healthy

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Device:
• PneuRIP
Measuring respiratory indices through Respiratory Inductance Plethysmography

Other:
• biofeedback to assist with breathing
Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen

Locations

Country	Name	City	State
United States	Nemours/A.I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase angle	Measures synchrony between chest and stomach	8 weeks