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Active, Not Recruiting

NCT Number: NCT06561334

Spasmodic Dysphonia Interviews

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spasmodic Dysphonia Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Quality of Life Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin injections

Procedure

Botulinum toxin injection to ease spasms of vocal cord

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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