Spasmodic Dysphonia Interviews

September 23, 2025 updated by: Manchester University NHS Foundation Trust

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom
        • Manchester University NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with diagnosed Spasmodic Dysphonia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spasmodic Dysphonia patients
Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.
Procedure: Botulinum toxin injections
Botulinum toxin injection to ease spasms of vocal cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, which is expected to be a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
What role do botulinum toxin injections play in the socio-economic livelihood of Spasmodic Dysphonia patients?
Time Frame: 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.
Through study completion, which is expected to be a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Investigators

  • Principal Investigator: Sadie Khwaja, MBChB, Manchester University NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Actual)

August 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B01796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to the sensitive nature of the study content and the interview study design

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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