Spasmodic Dysphonia Interviews

Not yet recruiting

• Conditions: Quality of Life; Spasmodic Dysphonia
• Interventions: Procedure: Botulinum toxin injections

• Registration Number: NCT06561334
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-20
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-09
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spasmodic Dysphonia patients	Botulinum toxin injections	Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.

Primary Outcome Measures

Name	Time	Method
Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?	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 Outcome Measures

Name	Time	Method
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	Outcome will be measured through qualitative analysis of participant answers regarding how receiving Botulinum toxin injections may improve their livelihood.