An interventional study of Voice Exercise in Adductor Spasmodic Dysphonia, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care
Among 71 studies in Dysphonia with a site in United States — 20 open to participants now, 21 under way, 1 of them phase 3. Dysphonia · United States.
Among the 71 studies in Dysphonia with a site in United States, this one is the 40th largest by enrollment of the 53 interventional ones, is one of 2 that started in 2014, is one of 31 with no phase, and was the 28th registered.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →20 of the 71 studies in Dysphonia with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 25 Dysphonia studies recruiting now, 8 (32%) set no upper age limit and 9 (36%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 21 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →71 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 2 started in 2014.
Median enrollment 32 across the 53 interventional studies, 170 across the 18 observational. Of the 41 that completed or were terminated, 17 (41%) have results posted.
2 of 71 have an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 2 studies filed under Dysphonia — fewer than ten, so there is no comparison to draw.
12 of the studies in Dysphonia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07145086Phase 3Texas Christian UniversityTranslaryngeal Vibration for Hyperfunctional Voice Disorders | 2027-04-30 |
| NCT06830174Yale UniversitytDCS for Laryngeal Dystonia | 2026-12 |
| NCT03702322University of ArizonaImproving Voice Production for Adults With Age-related Dysphonia | 2026-12-30 |
| NCT05095740MGH Institute of Health ProfessionsEffects of Neuromodulation in Laryngeal Dystonia | 2026-12-31 |
| NCT07443891University of MinnesotaBrain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia | 2027-02-28 |
Among the 71 studies in Dysphonia with a site in United States, from their registry updates:
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.
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.
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Exclusion Criteria:
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.
Behavioral: Voice Exercise
Randomized participants in this group will undergo 45 minutes of voice rest.
Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.
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.
Time frame: Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 year.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2014 to primary completion in Jul 2018, 47 months.
Of 44 non-industry interventional studies with no phase under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 47 months is above that.
Counting every sponsor, half of 44 studies reached it within 26 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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