Trial · NCT01961297
Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response
NCT01961297, Phase 2, Completed, Kristina Simonyan; results first posted 2017-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response. Trials, record NCT01961297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01961297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response
- NCT number
- NCT01961297
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Kristina Simonyan
- Conditions
- Spasmodic Dysphonia, Voice Tremor
- Interventions
- Sodium oxybate
- First posted
- 2013-10-11
- Last updated
- 2017-11-22
- Results first posted
- 2017-11-22
- Limitations and caveats
- A limitation of this study was reliance on patients' self-reports of alcohol response.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Reported Positive Effects. | Day 1 | Number of participants who had reported positive effects of at least one alcohol drink on their voice symptoms |
| Secondary | Number of Voice Breaks | baseline and Day 1 | The number of SD-characteristic voice breaks in each sentence at pre-drug and post-drug assessment |
| Secondary | Voice Harshness Severity | baseline and Day 1 | Visual analog scale of severity (0 for none, 100 for most severe/profound) |
| Secondary | Breathlessness Severity | baseline and Day 1 | Visual analog scale of severity (0 for none, 100 for most severe/profound) |
| Secondary | Voice Tremor Severity | baseline and Day 1 | Visual analog scale of severity (0 for none, 100 for most severe/profound) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Reported Positive Effects. | Day 1 | Only alcohol-responsive participants were in this analysis which is 23 from the SD group and 22 from the SD/VT group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Voice Breaks | baseline and Day 1 | Only alcohol-responsive participants were included in analysis | voice breaks | MEAN |
| SECONDARY | Voice Harshness Severity | baseline and Day 1 | Only alcohol-responsive participants were included in analysis | units on a scale | MEAN |
| SECONDARY | Breathlessness Severity | baseline and Day 1 | Only alcohol-responsive participants were included in analysis | units on a scale | MEAN |
| SECONDARY | Voice Tremor Severity | baseline and Day 1 | Only alcohol-responsive participants with voice tremors were included in analysis | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Reported Positive Effects. | Spasmodic Dysphonia | 17 | Participants | ||
| Number of Participants Who Reported Positive Effects. | Spasmodic Dysphonia/Voice Tremor | 20 | Participants | ||
| Number of Voice Breaks | Spasmodic Dysphonia | Baseline - pre-treatment | 3.6 | Standard Deviation 1.6 | voice breaks |
| Number of Voice Breaks | Spasmodic Dysphonia/Voice Tremor | Baseline - pre-treatment | 4.1 | Standard Deviation 2.5 | voice breaks |
| Number of Voice Breaks | Spasmodic Dysphonia | Day 1 - post treatment | 2.6 | Standard Deviation 1.8 | voice breaks |
| Number of Voice Breaks | Spasmodic Dysphonia/Voice Tremor | Day 1 - post treatment | 2.8 | Standard Deviation 2.0 | voice breaks |
| Voice Harshness Severity | Spasmodic Dysphonia | Baseline - pre treatment | 48.0 | Standard Deviation 25.3 | units on a scale |
| Voice Harshness Severity | Spasmodic Dysphonia/Voice Tremor | Baseline - pre treatment | 58.3 | Standard Deviation 23.1 | units on a scale |
| Voice Harshness Severity | Spasmodic Dysphonia | Day 1 - post treatment | 42.8 | Standard Deviation 23.6 | units on a scale |
| Voice Harshness Severity | Spasmodic Dysphonia/Voice Tremor | Day 1 - post treatment | 31.6 | Standard Deviation 17.8 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spasmodic Dysphonia | 30 | |
| Overall Study | STARTED | Spasmodic Dysphonia/Voice Tremor | 23 | |
| Overall Study | COMPLETED | Spasmodic Dysphonia | 28 | |
| Overall Study | COMPLETED | Spasmodic Dysphonia/Voice Tremor | 22 | |
| Overall Study | NOT COMPLETED | Spasmodic Dysphonia | 2 | |
| Overall Study | NOT COMPLETED | Spasmodic Dysphonia/Voice Tremor | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Slight lightheadedness | Nervous system disorders | Spasmodic Dysphonia | 11 | 28 | |
| other | Slight lightheadedness | Nervous system disorders | Spasmodic Dysphonia/Voice Tremor | 4 | 22 | |
| other | Drowsiness | Nervous system disorders | Spasmodic Dysphonia | 0 | 28 | |
| other | Drowsiness | Nervous system disorders | Spasmodic Dysphonia/Voice Tremor | 1 | 22 | |
| other | Dizziness | Nervous system disorders | Spasmodic Dysphonia | 5 | 28 | |
| other | Dizziness | Nervous system disorders | Spasmodic Dysphonia/Voice Tremor | 5 | 22 | |
| other | Headache | Nervous system disorders | Spasmodic Dysphonia | 1 | 28 | |
| other | Headache | Nervous system disorders | Spasmodic Dysphonia/Voice Tremor | 0 | 22 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spasmodic Dysphonia | 0 | 28 |
| Total, all-cause mortality | Spasmodic Dysphonia/Voice Tremor | 0 | 22 |
| Total, other adverse events | Spasmodic Dysphonia | 14 | 28 |
| Total, other adverse events | Spasmodic Dysphonia/Voice Tremor | 10 | 22 |
| Total, serious adverse events | Spasmodic Dysphonia | 0 | 28 |
| Total, serious adverse events | Spasmodic Dysphonia/Voice Tremor | 0 | 22 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DC012545 | Central mechanisms and treatment response of sodium oxybate in spasmodic dysphonia and voice tremor | SIMONYAN, KRISTINA | MASSACHUSETTS EYE AND EAR INFIRMARY | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2012 to 2021 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Spasmodic Dysphonia vs Spasmodic Dysphonia/Voice Tremor: Number of Participants Who Reported Positive Effects. | Trial comparisons |
| Spasmodic Dysphonia vs Spasmodic Dysphonia/Voice Tremor: deaths from any cause | Trial comparisons |
| Spasmodic Dysphonia vs Spasmodic Dysphonia/Voice Tremor: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01961297
GET https://conductscience.org/api/trials/v1/NCT01961297/registered