Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT06561334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spasmodic Dysphonia Interviews
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}, {'id': 'D014832', 'term': 'Voice Disorders'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?', 'timeFrame': 'Through study completion, which is expected to be a year', 'description': 'Outcome will be measured through qualitative analysis of participant answers regarding how the target condition, spasmodic dysphonia, affects the social and economic aspects of their livelihood.'}], 'secondaryOutcomes': [{'measure': 'What role do botulinum toxin injections play in the socio-economic livelihood of Spasmodic Dysphonia patients?', 'timeFrame': 'Through study completion, which is expected to be a year', 'description': 'Outcome will be measured through qualitative analysis of participant answers regarding how receiving Botulinum toxin injections may improve their livelihood.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qualitative study', 'Interviews', 'Quality of life', 'Spasmodic Dysphonia', 'Botulinum toxin', 'Laryngology', 'Voice disorder'], 'conditions': ['Spasmodic Dysphonia', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "Previous research has shown that patients with voice disorders often have a lower quality of life and struggle with employment. Spasmodic Dysphonia (SD) is a voice disorder that causes abrupt and uncontrollable spasms of the voice box, often resulting in the person having lifelong changes in their voice and speech pattern. The current mainstay of treatment is injecting botulinum toxin (BT) injections into the vocal cord to ease the spasms. The same research team conducted a pilot study in April 2021 on patients with SD. The pilot study used questionnaires and short interviews to understand the livelihood of 10 SD patients. It displayed that SD may impact patients' quality of life. The investigators now aim to run an official research project, ethically approved, to explore the following questions further:\n\n1. Does SD impact the socio-economic lives of its patients? If so, how?\n2. What role does BT play in the socio-economic livelihood of SD patients?\n\nTo answer these questions, the investigators aim to interview 20 patients with Spasmodic Dysphonia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with diagnosed Spasmodic Dysphonia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.\n\nExclusion Criteria:\n\n* Below 18 years of age; additional laryngeal condition(s) severely affecting voice.'}, 'identificationModule': {'nctId': 'NCT06561334', 'briefTitle': 'Spasmodic Dysphonia Interviews', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'The Socioeconomic Impact of Spasmodic Dysphonia Patients and the Role of Botulinum Toxin', 'orgStudyIdInfo': {'id': 'B01796'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spasmodic Dysphonia patients', 'description': 'Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.', 'interventionNames': ['Procedure: Botulinum toxin injections']}], 'interventions': [{'name': 'Botulinum toxin injections', 'type': 'PROCEDURE', 'description': 'Botulinum toxin injection to ease spasms of vocal cord', 'armGroupLabels': ['Spasmodic Dysphonia patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sadie Khwaja, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manchester University NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to the sensitive nature of the study content and the interview study design'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}