CClinicalTrials.gg
Status unknownNCT03129087Updated Aug 16, 2018

The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia

An interventional study of Vocal rest versus vocalization in Adductor Spasmodic Dysphonia, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Status unknown at 1 site in Canada. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-16.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
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Study summary

This study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.

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Conditions studied

  • Adductor Spasmodic Dysphonia
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In context

Dysphonia

131 studies on the registry are indexed under Dysphonia; 34 are open to participants now.

This study's planned enrollment of 20 is below the median of 39 across 94 interventional studies indexed under Dysphonia.

Browse Dysphonia studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with adductor spasmodic dysphonia (ADSD) by an experienced neurologist and otolaryngologist. ADSD patients who have been stabilized on their treatment dose for at least 2 treatment cycles.

Exclusion criteria

Exclusion Criteria:

  • Diagnosed with another neurological disorder that is combined with ADSD (i.e. Parkinson's disease and ADSD). Previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Vocal activity

    The vocal activity arm will require the participant to remain in the clinic and read aloud continuously for a period of one hour after a botulinum toxin injection

    Behavioral: Vocal rest versus vocalization

  • Experimental
    Vocal rest

    The vocal rest arm will require the participant to remain in the clinic and remain on complete vocal rest for a period of one hour after a botulinum toxin injection

    Behavioral: Vocal rest versus vocalization

Interventions

  • BehavioralVocal rest versus vocalization

    A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection

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What researchers measure

Primary outcomes

  1. Severity of spasmodic dysphonia symptoms

    Acoustic measures and perceptual ratings of vocal spasm severity

    Time frame: Six weeks post-treatment

  2. Patient-reported outcome measures of symptoms and communication

    Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy

    Time frame: six weeks post-treatment

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Study locations

1 site
  • LawsonHRI
    London, Ontario N6G 1H1, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03129087
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Sponsor
First posted
Apr 26, 2017
Start date
May 23, 2017
Primary completion
May 1, 2019 (estimated)
Completion
May 1, 2019 (estimated)
Last update
Aug 16, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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