Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT05473169
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swallowing Evaluation in VF Immobility
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To calculate the incidence of swallowing dysfunction in people with vocal fold immobility', 'timeFrame': 'Baseline', 'description': 'Incidence of swallowing dysfunction in patients with vocal fold immobility will be determined by the Statistical Package for the Social Sciences (SPPS) after the diagnosis of swallowing dysfunction by fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallow study (VFSS)'}], 'secondaryOutcomes': [{'measure': 'Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients', 'timeFrame': 'Baseline', 'description': 'To detect which swallowing phase is causing the dysfunction by using Statistical Package for the Social Sciences (SPSS) program'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Swallowing Disorder']}, 'referencesModule': {'references': [{'pmid': '11014880', 'type': 'BACKGROUND', 'citation': 'Heitmiller RF, Tseng E, Jones B. Prevalence of aspiration and laryngeal penetration in patients with unilateral vocal fold motion impairment. Dysphagia. 2000 Fall;15(4):184-7. doi: 10.1007/s004550000026.'}, {'pmid': '16359143', 'type': 'BACKGROUND', 'citation': "Ollivere B, Duce K, Rowlands G, Harrison P, O'Reilly BJ. Swallowing dysfunction in patients with unilateral vocal fold paralysis: aetiology and outcomes. J Laryngol Otol. 2006 Jan;120(1):38-41. doi: 10.1017/S0022215105003567. Epub 2005 Nov 25."}]}, 'descriptionModule': {'briefSummary': 'Vocal fold immobility (VFI) often results in significant problems with dysphonia, dysphagia, and decreased cough strength. As one element of the dysphagia potentially associated with vocal fold immobility,\n\naspiration may create significant morbidity for these patients. An estimated 38% to 53% of patients with\n\nuntreated VFI have swallowing difficulties with aspiration.\n\nVocal fold immobility has important implication on the laryngeal airway protection during respiration,\n\nphonation and swallowing. It is the most common neurological laryngeal disorder.\n\nThe immobility may be caused by neck and thoracic surgery. which can impair the innervation of the pharynx,\n\nupper esophageal sphincter (U.E.S) and proximal esophagus but may also be due to malignancy,trauma,\n\nIntracranial causes,or may be idiopathic', 'detailedDescription': 'Besides the voice alteration, the lesion that causes of vocal fold immobility should also affect the pharyngeal phase of swallowing.\n\nIt was suggested that dysphagia in patient with vocal fold immobility has multifactor causes ; including limited airway protection and decrease laryngopharyngeal sensation based on the finding of the flexible endoscopy.\n\nAnother study revealed that pharyngeal phase abnormalities such as delayed initiation of swallowing, reduced laryngeal elevation, and reduced upper esophageal sphincter (UES) opening were found in video fluoroscopic swallowing studies (VFSS).\n\nSeveral studies on the swallowing difficulties of patient with vocal fold immobility has been performed and reported that nearly 56% of these patients immobility have swallowing dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Vocal fold immobility', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:above 18.\n2. Gender:both sexes will be included in the study.\n\nExclusion Criteria:\n\n1. patients with structural abnormalities of oral cavity, pharynx or larynx.\n2. previous vocal fold injection or voice therapy.\n3. other causes of dysphagia: esophageal cancer or spasm , gastric cancer, cancer larynx,or radio therapy .\n4. . Patients with history of heart burn , acid regurgitation ,\n5. other neurological disease ,stroke, hypothyroidism or dyspnea.'}, 'identificationModule': {'nctId': 'NCT05473169', 'briefTitle': 'Swallowing Evaluation in VF Immobility', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Swallowing in Patients With Vocal Folds Immobility', 'orgStudyIdInfo': {'id': 'Swallowing in VF immobility'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with Vocal fold immobility', 'interventionNames': ['Device: Videofluoroscopy']}, {'label': 'Control', 'description': "Normal volunteer don't have dysphagia , neurological diseases , heart burn and acid regurgitation", 'interventionNames': ['Device: Videofluoroscopy']}], 'interventions': [{'name': 'Videofluoroscopy', 'type': 'DEVICE', 'otherNames': ['Nasofibroscopy'], 'description': 'Swallowing assessment', 'armGroupLabels': ['Control', 'Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Zakaria Ahmed Elbakry, Resident', 'role': 'CONTACT', 'email': 'mohamedelbakry970@gmail.com', 'phone': '01101941217'}, {'name': 'Eman Sayed', 'role': 'CONTACT', 'email': 'eshh2003@yahoo.com', 'phone': '01004082014'}], 'overallOfficials': [{'name': 'Assiut', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Non-afiliated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohamed Zakaria Ahmed Elbakry', 'investigatorAffiliation': 'Assiut University'}}}}