Back to resultsThe Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
Primary Purpose
Adductor Spasmodic Dysphonia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vocal rest versus vocalization
Sponsored by
About this trial
This is an interventional treatment trial for Adductor Spasmodic Dysphonia
Eligibility 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.)
Sites / Locations
- LawsonHRI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vocal activity
Vocal rest
Arm Description
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
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
Outcomes
Primary Outcome Measures
Severity of spasmodic dysphonia symptoms
Acoustic measures and perceptual ratings of vocal spasm severity
Patient-reported outcome measures of symptoms and communication
Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT03129087
First Posted
April 19, 2017
Last Updated
August 15, 2018
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03129087
Brief Title
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
Official Title
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adductor Spasmodic Dysphonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vocal activity
Arm Type
Experimental
Arm Description
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
Arm Title
Vocal rest
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Vocal rest versus vocalization
Intervention Description
A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection
Primary Outcome Measure Information:
Title
Severity of spasmodic dysphonia symptoms
Description
Acoustic measures and perceptual ratings of vocal spasm severity
Time Frame
Six weeks post-treatment
Title
Patient-reported outcome measures of symptoms and communication
Description
Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy
Time Frame
six weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
LawsonHRI
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1H1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
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