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

NCT ID: NCT03129087

Last Updated: 2018-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2019-05-01

Brief Summary

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

Detailed Description

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Conditions

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Adductor Spasmodic Dysphonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Vocal rest versus vocalization

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Vocal rest versus vocalization

Intervention Type BEHAVIORAL

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

Interventions

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Vocal rest versus vocalization

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LawsonHRI

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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LawsonHRI2

Identifier Type: -

Identifier Source: org_study_id

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