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Clinical Trials/NCT06561334
NCT06561334
Active, not recruiting
Not Applicable

The Socioeconomic Impact of Spasmodic Dysphonia Patients and the Role of Botulinum Toxin

Manchester University NHS Foundation Trust1 site in 1 country20 target enrollmentAugust 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spasmodic Dysphonia
Sponsor
Manchester University NHS Foundation Trust
Enrollment
20
Locations
1
Primary Endpoint
Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

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:

  1. Does SD impact the socio-economic lives of its patients? If so, how?
  2. What role does BT play in the socio-economic livelihood of SD patients?

To answer these questions, the investigators aim to interview 20 patients with Spasmodic Dysphonia.

Registry
clinicaltrials.gov
Start Date
August 20, 2024
End Date
September 30, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.

Exclusion Criteria

  • Below 18 years of age; additional laryngeal condition(s) severely affecting voice.

Outcomes

Primary Outcomes

Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?

Time Frame: Through study completion, which is expected to be a year

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.

Secondary Outcomes

  • What role do botulinum toxin injections play in the socio-economic livelihood of Spasmodic Dysphonia patients?(Through study completion, which is expected to be a year)

Study Sites (1)

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