Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-28 @ 9:37 AM
Study NCT ID:
NCT05177861
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020424', 'term': 'Ulnar Neuropathies'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburg Sleep Quality Index', 'timeFrame': '10 minutes.', 'description': 'sleep evaluation between 0 and 21 points, higher scores mean a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulnar Neuropathies']}, 'descriptionModule': {'briefSummary': 'Regardless of the cause of ulnar nerve entrapment neuropathy, we are planning to investigate the relationship between sleep quality disorder that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)\n* to be between the ages of 18-65\n* be give informed consent\n\nExclusion Criteria:\n\n* malignancy\n* surgical history in the ipsilateral upper extremity\n* sleep apnea\n* narcolepsy'}, 'identificationModule': {'nctId': 'NCT05177861', 'briefTitle': 'The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy', 'orgStudyIdInfo': {'id': '100th year University Van'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Electromyelography', 'description': 'EMG will be performed only once to determine the ulnar nerve entrapment site in patients.', 'interventionNames': ['Diagnostic Test: EMG']}], 'interventions': [{'name': 'EMG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Electromyelography', 'armGroupLabels': ['Electromyelography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65040', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Yuzuncu Yil University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Volkan Şah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yüzüncü Yıl Üniversitesi Tıp Fakültesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Volkan Şah', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}