Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT05791435
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012119', 'term': 'Respiration'}], 'ancestors': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trahman@nemours.org', 'phone': '302 651 6831', 'title': 'Tariq Rahman', 'organization': 'Nemours Children Health System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'description': "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", 'eventGroups': [{'id': 'EG000', 'title': 'Biofeedback Group', 'description': 'This group will receive biofeedback to assist with breathing\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography\n\nbiofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Biofeedback Group', 'description': 'This group will only have their breathing monitored after instruction\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Group', 'description': 'This group will receive biofeedback to assist with breathing\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography\n\nbiofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen'}, {'id': 'OG001', 'title': 'Non-Biofeedback Group', 'description': 'This group will only have their breathing monitored after instruction\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '13.65', 'groupId': 'OG000'}, {'value': '41', 'spread': '12.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biofeedback Group', 'description': 'This group will receive biofeedback to assist with breathing\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography\n\nbiofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen'}, {'id': 'FG001', 'title': 'Non-Biofeedback Group', 'description': 'This group will only have their breathing monitored after instruction\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruited in Medical clinic. Dates are 5/1/23-8/29/23'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Biofeedback Group', 'description': 'This group will receive biofeedback to assist with breathing\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography\n\nbiofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen'}, {'id': 'BG001', 'title': 'Non-Biofeedback Group', 'description': 'This group will only have their breathing monitored after instruction\n\nPneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.14', 'spread': '2.79', 'groupId': 'BG000'}, {'value': '16.57', 'spread': '1.27', 'groupId': 'BG001'}, {'value': '15.36', 'spread': '2.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-03', 'size': 695864, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-27T18:26', 'hasProtocol': True}, {'date': '2022-01-03', 'size': 121580, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-27T18:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2023-03-17', 'resultsFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-07', 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Angle', 'timeFrame': '8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth with Chronic pain Prescribed yoga therapy as part of treatment plan\n\nExclusion Criteria:\n\n* Otherwise healthy'}, 'identificationModule': {'nctId': 'NCT05791435', 'briefTitle': 'Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.', 'orgStudyIdInfo': {'id': '1904079'}, 'secondaryIdInfos': [{'id': '3R41AT012155-01S1', 'link': 'https://reporter.nih.gov/quickSearch/3R41AT012155-01S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biofeedback group', 'description': 'This group will receive biofeedback to assist with breathing', 'interventionNames': ['Device: PneuRIP', 'Other: biofeedback to assist with breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Biofeedback group', 'description': 'This group will only have their breathing monitored after instruction', 'interventionNames': ['Device: PneuRIP']}], 'interventions': [{'name': 'PneuRIP', 'type': 'DEVICE', 'otherNames': ['Non-invasive breathing monitor'], 'description': 'Measuring respiratory indices through Respiratory Inductance Plethysmography', 'armGroupLabels': ['Biofeedback group', 'Non-Biofeedback group']}, {'name': 'biofeedback to assist with breathing', 'type': 'OTHER', 'description': 'Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen', 'armGroupLabels': ['Biofeedback group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours/A.I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Research Engineer', 'investigatorFullName': 'Tariq Rahman', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}