Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT03494361
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2018-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Dysphagia by 6-chnnel Surface Electromyography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency', 'timeFrame': 'once at study, when patient enrolled', 'description': 'the latency of muscular activation'}], 'secondaryOutcomes': [{'measure': 'duration', 'timeFrame': 'once at study, when patient enrolled', 'description': 'the contractile duration of evaluated muscles'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deglutition disorders', 'electromyography'], 'conditions': ['Deglutition Disorders']}, 'descriptionModule': {'briefSummary': 'The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity.\n\nMany swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process.\n\nFirst hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role.\n\nSecond hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.', 'detailedDescription': 'Inclusion criteria\n\nInclusion criteria of healthy older adults : Age \\> 60, without dysphagia, comorbidity\n\nInclusion criteria of young control group\n\n: Age \\< 60, without dysphagia, comorbidity\n\nNo prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing.\n\nSurface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy participants', 'eligibilityCriteria': 'Inclusion Criteria of old group\n\n* Age \\> 60, without dysphagia, comorbidity\n\nInclusion Criteria of young control group\n\n* Age \\< 60, without dysphagia, comorbidity'}, 'identificationModule': {'nctId': 'NCT03494361', 'briefTitle': 'Evaluation of Dysphagia by 6-chnnel Surface Electromyography', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation', 'orgStudyIdInfo': {'id': 'B-1604/344-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young normal group', 'description': 'normal participants below 60 years'}, {'label': 'Old normal group', 'description': 'normal participants above 60 years'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Ju Seok Ryu', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}