Spasmodic DysphoniaNCT06561334
Spasmodic Dysphonia Interviews
An observational study of Spasmodic Dysphonia and Quality of Life, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasmodic Dysphonia, Quality of Life
- What is being tested?
- Botulinum toxin injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diagnosed Spasmodic Dysphonia
Who may be able to join
- Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.
Who cannot join
- Below 18 years of age; additional laryngeal condition(s) severely affecting voice.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester
About this study
Official title: 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:
- Does SD impact the socio-economic lives of its patients? If so, how?
- 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.
- Conditions
- Spasmodic Dysphonia, Quality of Life
- Being tested
- Botulinum toxin injections
- Keywords
- Qualitative study, Interviews, Quality of life, Spasmodic Dysphonia, Botulinum toxin, Laryngology, Voice disorder
- Medical subject headings
- Dysphonia, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionsProcedure or surgery
Botulinum toxin injection to ease spasms of vocal cord
| Study group | Role | What they receive |
|---|---|---|
| Spasmodic Dysphonia patients | Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection. Receives: Procedure: Botulinum toxin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, which is expected to be a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Aug 2024
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasmodic DysphoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sadie Khwaja, MBChB, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561334
- Sponsor's protocol ID
- B01796
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the study content and the interview study design
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Socioeconomic Impact of Spasmodic Dysphonia Patients and the Role of Botulinum Toxin
- ClinicalTrials.gov ID
- NCT06561334
- Acronym / sponsor ID
- B01796
- Conditions
- Spasmodic Dysphonia, Quality of Life
- Keywords
- Qualitative study, Interviews, Quality of life, Spasmodic Dysphonia, Botulinum toxin, Laryngology, Voice disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does SD impact the socio-economic lives of its patients? If so, how?
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spasmodic Dysphonia patients | – | Procedure: Botulinum toxin injectionsAdults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosed Spasmodic Dysphonia
Key inclusion criteria (1 listed)
- Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.
Key exclusion criteria (1 listed)
- Below 18 years of age; additional laryngeal condition(s) severely affecting voice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injectionsBotulinum toxin injection to ease spasms of vocal cord | Procedure or surgery | Spasmodic Dysphonia patients |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the study content and the interview study design
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadie Khwaja, MBChB principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasmodic Dysphonia and Quality of Life, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.