Could a sleep drug calm shaky voices? small study aims to find out.
NCT ID NCT07041203
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether a long-acting form of sodium oxybate (Lumryz) can improve voice symptoms in 8 adults with spasmodic dysphonia or voice tremor. Participants will take the drug and have their voice and brain activity measured. The goal is to see if the drug works and how long the effect lasts.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study 3. Males and females 4. Age 21-80 years 5. Documented diagnosis of alcohol-responsive laryngeal dystonia 6. Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies 7. Willingness to adhere to the study intervention regimen Exclusion Criteria: 1. The incapability of giving informed consent 2. Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding 3. Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria 4. Moderate to severe congestive heart failure 5. Cognitive impairment (MoCA \< 26) 6. Past or present suicidal ideations (according to C-SSRS) 7. Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria 8. Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection 9. Increased daytime sleepiness (Epworth Sleepiness Scale (ESS\>10)) 10. Past or present history of any neurological disorders (except for LD and co-occurring voice tremor), such as stroke, movement disorders, brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence. 11. Past or present history of any psychiatric problems, such as schizophrenia, major and/or bipolar depression, or obsessive-compulsive disorder 12. Current use of medication(s) affecting the central nervous system 13. Past or present history of brain and/or laryngeal surgery 14. Presence of certain tattoos, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that are not MRI comparable and/or cannot be removed for the purpose of MRI study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts Eye and Ear
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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