Spasmodic Dysphonia Interviews

NCT06561334 | Active Not Recruiting

• 1 other identifier: B01796
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Spasmodic Dysphonia; Quality of Life

Keywords

Qualitative study; Interviews; Quality of life; Spasmodic Dysphonia; Botulinum toxin; Laryngology; Voice disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  Through study completion, which is expected to be a year

Secondary Outcomes (1)

• 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 Arms (1)

Spasmodic Dysphonia patients

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

Procedure: Botulinum toxin injections

Interventions

Botulinum toxin injections PROCEDURE

Botulinum toxin injection to ease spasms of vocal cord

Spasmodic Dysphonia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosed Spasmodic Dysphonia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Dysphonia; Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sadie Khwaja, MBChB

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 20, 2024
• Study Start: August 20, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)