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CompletedNCT06561334Updated Sep 23, 2026

Spasmodic Dysphonia Interviews

An observational study in Spasmodic Dysphonia and Quality of Life, sponsored by Manchester University NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Manchester University NHS Foundation Trust · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spasmodic Dysphonia
  • Quality of Life

Keywords

  • Qualitative study
  • Interviews
  • Quality of life
  • Spasmodic Dysphonia
  • Botulinum toxin
  • Laryngology
  • Voice disorder
03

In context

Dysphonia

132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.

This study's enrollment of 22 is below the median of 123 across 40 observational studies indexed under Dysphonia.

Browse Dysphonia studies →

Lead sponsor

Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with diagnosed Spasmodic Dysphonia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Below 18 years of age; additional laryngeal condition(s) severely affecting voice.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • Spasmodic Dysphonia patients

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

    Procedure: Botulinum toxin injections

Interventions

  • ProcedureBotulinum toxin injections

    Botulinum toxin injection to ease spasms of vocal cord

06

What researchers measure

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.

    Time frame: 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?

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

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

07

Study locations

1 site
  • Manchester University NHS Foundation Trust
    Manchester, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to the sensitive nature of the study content and the interview study design

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2024 to primary completion in Aug 2025, 12 months.

Of 18 observational studies under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 193. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2024
First posted
Aug 20, 2024
StartActual
Aug 20, 2024
Primary completionActual
Aug 31, 2025
CompletionActual
Sep 30, 2025
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06561334
Responsible party
Sponsor
First posted
Aug 20, 2024
Start date
Aug 20, 2024
Primary completion
Aug 31, 2025
Completion
Sep 30, 2025
Last update
Sep 23, 2026

Study contacts

Sadie Khwaja, MBChB
principal investigator · Manchester University NHS Foundation Trust

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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