Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-01 @ 7:59 AM
Study NCT ID:
NCT05713968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-06
First Post:
2023-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'upper esophageal sphincter pressure', 'timeFrame': '30 minutes', 'description': 'upper esophageal sphincter opening ability questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Upper Esophageal Sphincter Relaxing Pressure']}, 'descriptionModule': {'briefSummary': "patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.", 'detailedDescription': 'This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cervical spondylolysis patients with swallowing difficulty feelings could attend this study. The researchers will hope to help these patients to find the dysphagia mechanisms. If they have to receive early swallowing rehabilitation, we could transfer them and give the rehabilitation physicians advices.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery\n* patients with associated swallowing difficulty symptoms\n\nExclusion Criteria:\n\n* major organ dysfunction, such as renal insufficiency or bleeding tendency'}, 'identificationModule': {'nctId': 'NCT05713968', 'briefTitle': 'Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients', 'orgStudyIdInfo': {'id': '202211062DIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with EAT-10 higher than 3 or frailty questionnaire higher than 2', 'description': 'patients may have high risk of aspiration', 'interventionNames': ['Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM']}, {'label': 'patients with EAT-10 lower than 3 or frailty questionnaire lower than 2', 'description': 'patients may have low risk of aspiration', 'interventionNames': ['Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2']}], 'interventions': [{'name': 'patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM', 'type': 'OTHER', 'description': 'patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM', 'armGroupLabels': ['patients with EAT-10 higher than 3 or frailty questionnaire higher than 2']}, {'name': 'patients with EAT-10 lower than 3 or frailty questionnaire lower than 2', 'type': 'OTHER', 'description': 'patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM', 'armGroupLabels': ['patients with EAT-10 lower than 3 or frailty questionnaire lower than 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chih-Jun Lai, MD', 'role': 'CONTACT', 'email': 'littlecherrytw@gmail.com', 'phone': '+886223123456'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'ethical issue'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}