Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT00629850
Status:
TERMINATED
Last Update Posted:
2019-05-08
First Post:
2008-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cr23@txstate.edu', 'phone': '512-245-3794', 'title': 'Chris Russian, Associate Professor', 'organization': 'Texas State Respiratory Care Department'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Unable to recruit subjects for the study'}}, 'adverseEventsModule': {'timeFrame': '8 weeks of data collection', 'description': 'Other adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Powerlung Trainer Device', 'description': 'The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'This arm of the study will not receive the device.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Improvement in Sleep Quality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Powerlung Trainer Device', 'description': 'The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.'}, {'id': 'OG001', 'title': 'Control', 'description': 'This arm of the study will not receive the device.'}], 'timeFrame': '10 weeks', 'description': 'Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only one participant completing the study. No analyses performed.'}, {'type': 'PRIMARY', 'title': 'Change in Maximum Voluntary Ventilation Using Pulmonary Function Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Powerlung Trainer Device', 'description': 'The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.'}, {'id': 'OG001', 'title': 'Control', 'description': 'This arm of the study will not receive the device.'}], 'timeFrame': '10 weeks', 'description': 'Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.', 'reportingStatus': 'POSTED', 'populationDescription': 'there was only one participant completing this study. No analyses performed.'}, {'type': 'PRIMARY', 'title': 'Change in Negative Inspiratory Force Using a Pressure Manometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Powerlung Trainer Device', 'description': 'The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.'}, {'id': 'OG001', 'title': 'Control', 'description': 'This arm of the study will not receive the device.'}], 'timeFrame': '10 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'there was only one participant completing this study. No analyses performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Powerlung Trainer Device', 'description': 'The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.'}, {'id': 'FG001', 'title': 'Control', 'description': 'This arm of the study will not receive the device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Powerlung Trainer Device', 'description': 'The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.'}, {'id': 'BG001', 'title': 'Control', 'description': 'This arm of the study will not receive the device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This was a single subject case study. No control subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'unable to recruit participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-27', 'studyFirstSubmitDate': '2008-02-25', 'resultsFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-17', 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Improvement in Sleep Quality.', 'timeFrame': '10 weeks', 'description': 'Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.'}, {'measure': 'Change in Maximum Voluntary Ventilation Using Pulmonary Function Device', 'timeFrame': '10 weeks', 'description': 'Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.'}, {'measure': 'Change in Negative Inspiratory Force Using a Pressure Manometer', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'respiratory muscle training', 'sleep quality'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the use of a respiratory resistance trainer will increase respiratory muscle strength, improve sleep quality and improve quality of life in individuals with spinal cord injury.\n\nHypothesis: Use of the respiratory resistance trainer will improve respiratory muscle strength, improve sleep quality, and improve quality of life among individuals with spinal cord injury.', 'detailedDescription': 'Individuals with spinal cord injury experience varying degrees of reduced muscle function. Those individuals with high level spinal cord injury, cervical region, may experience reduced diaphragm function. This reduction in function may affect daytime activities as well as sleep quality. Sleep quality in people with spinal cord injury is considered to be worse than sleep quality in the general population. The use of respiratory resistance training devices has been shown to increase muscle strength in people with spinal cord injury. There have been not studies to document potential improvements in sleep quality among individuals with spinal cord injury following respiratory resistance training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tetraplegia\n* quadriplegia\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT00629850', 'briefTitle': 'Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Texas State University, San Marcos'}, 'officialTitle': 'Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'TexasState 2008-29541'}, 'secondaryIdInfos': [{'id': 'IRB# 2008-29541', 'type': 'OTHER', 'domain': 'Texas State University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Powerlung Performer', 'description': 'The arm will receive the lung trainer device to use for 10 weeks', 'interventionNames': ['Device: Powerlung Performer']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control. This arm will not receive any device'}], 'interventions': [{'name': 'Powerlung Performer', 'type': 'DEVICE', 'otherNames': ['Respiratory resistance trainer'], 'description': 'Inspiratory/Expiratory muscle trainer', 'armGroupLabels': ['Powerlung Performer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas State University-San Marcos', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}], 'overallOfficials': [{'name': 'Lisa Lloyd, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Texas State University, San Marcos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas State University, San Marcos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chris Russian', 'investigatorAffiliation': 'Texas State University, San Marcos'}}}}