Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-03 @ 7:13 PM
Study NCT ID:
NCT05264961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Abnormalities in Dysphonic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in child behavior checklist', 'timeFrame': 'Baseline (before sessions) and after 3 months of sessions', 'description': 'scale assessing behavioral abnormalities of child as anxiety symptoms,depression symptoms,somatic symptoms,social problems,thought problems,attention problems,aggressive behavior and rule breaking behavior through asking parent of the child with minimal score 24 maximal score 100'}, {'measure': 'computerized speech lab.', 'timeFrame': 'Baseline (before sessions) and after 3 months of sessions', 'description': 'voice sample will be taken from child including vowels and connecting speech will be analyzed by computerized speech lab to evaluate change in acoustic parameters as jitter,shimmer,fundamental frequency and noise to harmonic ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphonia']}, 'descriptionModule': {'briefSummary': 'we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria :\n\n* dysphonic children age 6-12 years\n\nexclusion criteria:\n\n* age less than 6 years and more than 12 years,\n* hearing impaired,\n* neurological abnormalities.'}, 'identificationModule': {'nctId': 'NCT05264961', 'briefTitle': 'Behavioral Abnormalities in Dysphonic Children', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Behavioral Abnormalities in Dysphonic Children', 'orgStudyIdInfo': {'id': '01011747046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control group', 'description': 'dysphonic children without behavioral abnormalities', 'interventionNames': ['Behavioral: voice therapy']}, {'type': 'OTHER', 'label': 'study group', 'description': 'dysphonic children with behavioral abnormalities', 'interventionNames': ['Behavioral: voice therapy']}], 'interventions': [{'name': 'voice therapy', 'type': 'BEHAVIORAL', 'description': 'sessions of voice therapy', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Gerges Wasfy Gerges', 'investigatorAffiliation': 'Sohag University'}}}}