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

Sponsor
Nemours Children's Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05791435
Collaborator
(none)
20
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: PneuRIP
  • Other: biofeedback to assist with breathing
 N/A

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. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biofeedback group

This group will receive biofeedback to assist with breathing

Device: PneuRIP
Measuring respiratory indices through Respiratory Inductance Plethysmography
Other Names:
  • Non-invasive breathing monitor

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

    This group will only have their breathing monitored after instruction

    Device: PneuRIP
    Measuring respiratory indices through Respiratory Inductance Plethysmography
    Other Names:
  • Non-invasive breathing monitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Phase angle [8 weeks]

      Measures synchrony between chest and stomach

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Youth with Chronic pain Prescribed yoga therapy as part of treatment plan
    Exclusion Criteria:
    • Otherwise healthy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nemours Children's Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tariq Rahman, Principal Research Engineer, Nemours Children's Clinic
    ClinicalTrials.gov Identifier:
    NCT05791435
    Other Study ID Numbers:
    • 1904079
    First Posted:
    Mar 30, 2023
    Last Update Posted:
    Mar 30, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Mar 30, 2023