Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05452018
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2022-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of amplitude of signals for each type of swallowing and non-swallowing tasks', 'timeFrame': '2 hours', 'description': 'Measure of amplitude of signals for each type of swallowing tasks (of different types of food bowls) and non-swallowing tasks (turning the head, opening the mouth, talking, smiling)'}, {'measure': 'Measurement of integral of signals for each type of swallowing and non-swallowing tasks', 'timeFrame': '2 hours', 'description': 'Measure of integral of signals for each type of swallowing tasks (of different types of food bowls) and non-swallowing tasks (turning the head, opening the mouth, talking, smiling)'}, {'measure': 'Measurement of Root Mean Square of signals for each type of swallowing and non-swallowing tasks', 'timeFrame': '2 hours', 'description': 'Measure of Root Mean Square of signals for each type of swallowing tasks (of different types of food bowls) and non-swallowing tasks (turning the head, opening the mouth, talking, smiling)'}], 'primaryOutcomes': [{'measure': 'Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.', 'timeFrame': '2 hours', 'description': 'Absence or presence of visible activity on recorded signal during a swallow with the possibility to extract the TM moment (activation timing of the muscles of interest) of each muscle of interest'}], 'secondaryOutcomes': [{'measure': 'Measurement of the TM time variable', 'timeFrame': '2 hours', 'description': 'The TM time variable is assessed in milliseconds by intramuscular electromyography measurement and corresponding to activation timing of the muscles of interest'}, {'measure': 'Measurement of the TS time variable', 'timeFrame': '2 hours', 'description': 'Measure of TS time variable in milliseconds corresponding to passage of the food bolus through the upper esophageal sphincter. TS is assessed by signals acquired from the microphone.'}, {'measure': 'Measurement of the TD time variable', 'timeFrame': '2 hours', 'description': 'Measure of TD time variable in milliseconds corresponding to start of swallowing by activation of the submandibular area.TD is assessed by signals acquired from the microphone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Swallowing', 'Electromyogram', 'Intramuscular sensors', 'Muscular activity'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to show the feasibility of detecting the specific activity of 2 muscles during swallowing using invasive sensors in healthy volunteers.', 'detailedDescription': "Total laryngectomy, which involves removing the larynx and performing a tracheostomy, is the standard method of surgical treatment for advanced laryngeal cancer.\n\nIt changes the patient's life and has an significant impact on his overall quality of life.\n\nOver the last 10 years, numerous trials of artificial larynx implantation have been tested, but currently there is no method of implanting a system that detects the onset of a swallow.\n\nThe DEGLUTITION study aims to show the feasibility of detecting the specific activity of 2 muscles in swallowing using intramuscular electromyograms in healthy volunteers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) \\< 25\n* Affiliated with the social security plan or beneficiary of such a system\n* Having signed the informed consent\n\nExclusion Criteria: subjects\n\n* With chewing and/or swallowing disorders, or a history of chewing and/or swallowing disorders.\n* With bleeding disorders (including patients on anticoagulants)\n* With neurological disorders\n* With a history of cervical surgery\n* With immune deficiency\n* Participating in an interventional study that may interfere with this study\n* Protected person concerned by the articles L1121-5 to L1121-8 of the Public Health Code'}, 'identificationModule': {'nctId': 'NCT05452018', 'acronym': 'DEGLUTITION', 'briefTitle': 'Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers. Single-center, Prospective, Not-controlled, Not-randomized, Open-label Study.', 'orgStudyIdInfo': {'id': '38RC22.0096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First intervention group', 'description': 'Recordings of muscle activity during swallowing', 'interventionNames': ['Other: Intervention group']}], 'interventions': [{'name': 'Intervention group', 'type': 'OTHER', 'description': 'In healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks', 'armGroupLabels': ['First intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Ihab Atallah', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Ihab Atallah, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}, {'name': 'GIPSA-LAB', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}