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

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ClinicalTrials.gov Identifier: NCT03129087
Recruitment Status : Unknown
Verified August 2018 by Lawson Health Research Institute.
Recruitment status was:  Enrolling by invitation
First Posted : April 26, 2017
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Adductor Spasmodic Dysphonia Behavioral: Vocal rest versus vocalization Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The proposed study is a randomized, cross-over, clinical trial involving the comparison of two treatments (A and B) separated by a wash-out period (W). The patient participants will be randomized to one of the following two treatment orders: AWB or BWA.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
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
A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection
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
A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection


Outcome Measures
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Primary Outcome Measures :
  1. Severity of spasmodic dysphonia symptoms [ Time Frame: Six weeks post-treatment ]
    Acoustic measures and perceptual ratings of vocal spasm severity

  2. Patient-reported outcome measures of symptoms and communication [ Time Frame: six weeks post-treatment ]
    Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129087


Locations
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Canada, Ontario
LawsonHRI
London, Ontario, Canada, N6G 1H1
Sponsors and Collaborators
Lawson Health Research Institute
More Information
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03129087    
Other Study ID Numbers: LawsonHRI2
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysphonia
Hoarseness
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory