Adductor Spasmodic DysphoniaNCT03349086
Effects of Vocal Exercises for Spasmodic Dysphonia
A study testing Voice Exercise in people with Adductor Spasmodic Dysphonia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following Botox injections for adductor spasmodic dysphonia. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Adductor Spasmodic Dysphonia
- What is being tested?
- Voice Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2014to 25 Jul 2018
- Phase
- Interventional
- 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 21-70 age
- Diagnosed with pure adductor spasmodic dysphonia
- Completed 2 consecutive standard of care Botox injection into the thyroarytenoid (TA) and/or thyroarytenoid/lateral cricoarytenoid (TA/LCA) junction with the same dosage
Who cannot join
- Receiving Botox to other laryngeal or supraglottic musculature
- Other neuro-laryngological conditions
- Those with an average of less than two injections per year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
About this study
Official title: Effects of Vocal Exercise Following Botox Injection on Voice Handicap and Communicative Participation for Adductor Spasmodic Dysphonia
The purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following Botox injections for adductor spasmodic dysphonia.
Read the detailed description
Spasmodic dysphonia (SD) is a neurological disorder characterized by involuntary spasms of the vocal folds resulting in a strained and strangled voice quality. This disorder is quite disabling to patients who suffer from it, particularly affecting patients' quality of life. Botulinum toxin (Botox) has been found to be the most effective treatment for SD. The Botox is injected into the affected muscle resulting in temporary weakening of the muscle. The patients return for injections on average every 3 - 6 months.
There is a suggestion in the literature that increased diffusion of the Botox injectate could improve the effects of the injection. Furthermore, there is literature supporting the use of exercise to increase the diffusion of the Botox. Previous research examined the use of voluntary muscle activity vs. rest immediately following Botox injection for writer's cramp. It was found that the active condition resulted in greater reduction of muscle strength in the injected muscle. Another small study of 9 patients implemented intense exercise comprised of loud reading for one hour and a rest condition of total voice rest for 24 hours. They found that the exercise condition resulted in improved scores on the voice related-quality of life (V-RQOL) measure and concluded that improvement in results of Botox injections may be achieved more consistently with the implementation of exercise following the injection. The exercise used in this study was intense and may be contrary to the overall benefit as the subjects may experience phonotrauma. Timing of the exercise post-injection may also be a factor. Previous literature review revealed combined modality treatment of Botox injection only, Botox with therapy and Botox with sham treatment. They found no significant differences in acoustic stability, V-RQOL, or duration of injection benefit. However, the exercise was initiated 3 weeks post-injection and completed once per week for 5 weeks. Investigators aim to identify what might improve or extend the duration of botox injections for adductor Spasmodic dysphonia.
- Conditions
- Adductor Spasmodic Dysphonia
- Being tested
- Voice Exercise
- Keywords
- Botox Injection, Spasmodic, Dysphonia, Voice Therapy, Speech Therapy, Voice Rest
- Medical subject headings
- Dysphonia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice ExerciseBehavioural
Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.
| Study group | Role | What they receive |
|---|---|---|
| Voice Exercise | Active comparator | Randomized participants in this group will undergo 45 minutes of voice exercise, including sustained pitches and pitch glides on a variety of different vocal facilitators. Receives: Behavioral: Voice Exercise |
| Voice Rest | No intervention | Randomized participants in this group will undergo 45 minutes of voice rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A quantifiable difference between the effects of voice exercise vs. voice rest post Adductor Spasmodic Dysphonia botox treatment through analysis of the Voice Handicap Index Questionnaire.
Pre randomized condition and post 6 week and 12 week, participants will be asked to complete the Voice Handicap Index (VHI).
The VHI Questionnaire (Voice Handicap Index) is a 30-item questionnaire divided into 3 subsections (Functional, Physical, Emotional) and a Total which measures the effect of voice problems on quality of life. Individuals mark each item on this 30-item questionnaire on a scale from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered Normal, 12-28 is considered Mild Minimal handicap, 29-56 is considered Moderate Handicap, and 57-120 is considered severe handicap.
Measured: Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start28 Jul 2014
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adductor Spasmodic DysphoniaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will undergo one of two study conditions immediately following a standard of care Botox injections. One condition is a 45 minute voice rest condition and the other condition is a 45 minute voice exercise condition.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brienne Ruel, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349086
- Sponsor's protocol ID
- 2013-1746
- Status last verified
- May 2019
- First submitted
- 31 Aug 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vocal Exercise Following Botox Injection on Voice Handicap and Communicative Participation for Adductor Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT03349086
- Acronym / sponsor ID
- 2013-1746
- Conditions
- Adductor Spasmodic Dysphonia
- Keywords
- Botox Injection, Spasmodic, Dysphonia, Voice Therapy, Speech Therapy, Voice Rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Jul 2014 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 21 Nov 2017 (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.
The purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following Botox injections for adductor spasmodic dysphonia.
Detailed description
Spasmodic dysphonia (SD) is a neurological disorder characterized by involuntary spasms of the vocal folds resulting in a strained and strangled voice quality. This disorder is quite disabling to patients who suffer from it, particularly affecting patients' quality of life. Botulinum toxin (Botox) has been found to be the most effective treatment for SD. The Botox is injected into the affected muscle resulting in temporary weakening of the muscle. The patients return for injections on average every 3 - 6 months.
There is a suggestion in the literature that increased diffusion of the Botox injectate could improve the effects of the injection. Furthermore, there is literature supporting the use of exercise to increase the diffusion of the Botox. Previous research examined the use of voluntary muscle activity vs. rest immediately following Botox injection for writer's cramp. It was found that the active condition resulted in greater reduction of muscle strength in the injected muscle. Another small study of 9 patients implemented intense exercise comprised of loud reading for one hour and a rest condition of total voice rest for 24 hours. They found that the exercise condition resulted in improved scores on the voice related-quality of life (V-RQOL) measure and concluded that improvement in results of Botox injections may be achieved more consistently with the implementation of exercise following the injection. The exercise used in this study was intense and may be contrary to the overall benefit as the subjects may experience phonotrauma. Timing of the exercise post-injection may also be a factor. Previous literature review revealed combined modality treatment of Botox injection only, Botox with therapy and Botox with sham treatment. They found no significant differences in acoustic stability, V-RQOL, or duration of injection benefit. However, the exercise was initiated 3 weeks post-injection and completed once per week for 5 weeks. Investigators aim to identify what might improve or extend the duration of botox injections for adductor Spasmodic dysphonia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will undergo one of two study conditions immediately following a standard of care Botox injections. One condition is a 45 minute voice rest condition and the other condition is a 45 minute voice exercise condition.
| Arm | Type | Receives |
|---|---|---|
| Voice Exercise | Active comparator | Behavioral: Voice ExerciseRandomized participants in this group will undergo 45 minutes of voice exercise, including sustained pitches and pitch glides on a variety of different vocal facilitators. |
| Voice Rest | No intervention | –Randomized participants in this group will undergo 45 minutes of voice rest. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 21-70 age
- Diagnosed with pure adductor spasmodic dysphonia
- Completed 2 consecutive standard of care Botox injection into the thyroarytenoid (TA) and/or thyroarytenoid/lateral cricoarytenoid (TA/LCA) junction with the same dosage
Key exclusion criteria (3 listed)
- Receiving Botox to other laryngeal or supraglottic musculature
- Other neuro-laryngological conditions
- Those with an average of less than two injections per year
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 |
|---|---|---|
| Voice ExerciseVoice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators. | Behavioural | Voice Exercise |
Primary outcome
A quantifiable difference between the effects of voice exercise vs. voice rest post Adductor Spasmodic Dysphonia botox treatment through analysis of the Voice Handicap Index Questionnaire.
Time frame: Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 year.
Pre randomized condition and post 6 week and 12 week, participants will be asked to complete the Voice Handicap Index (VHI). The VHI Questionnaire (Voice Handicap Index) is a 30-item questionnaire divided into 3 subsections (Functional, Physical, Emotional) and a Total which measures the effect of voice problems on quality of life. Individuals mark each item on this 30-item questionnaire on a scale from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered Normal, 12-28 is considered Mild Minimal handicap, 29-56 is considered Moderate Handicap, and 57-120 is considered severe handicap.
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 May 2019.
- Individual participant dataSharing planned: No
Related trials for Adductor Spasmodic Dysphonia
RecruitingObservational study
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Laryngeal Dystonia, Adductor Spastic Dysphonia of Dystonia
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.
Brienne Ruel, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice Exercise in people with Adductor Spasmodic Dysphonia, run by University of Wisconsin, Madison at 1 site in United States.
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 4 inclusion and 3 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 May 2019. 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 States. 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?
A quantifiable difference between the effects of voice exercise vs. voice rest post Adductor Spasmodic Dysphonia botox treatment through analysis of the Voice Handicap Index Questionnaire. (time frame: Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 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 May 2019.