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

NCT03129087 | Unknown

• 1 other identifier: LawsonHRI2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adductor Spasmodic Dysphonia

Outcome Measures

Primary Outcomes (2)

• Severity of spasmodic dysphonia symptoms

  Acoustic measures and perceptual ratings of vocal spasm severity

  Six weeks post-treatment

• Patient-reported outcome measures of symptoms and communication

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

  six weeks post-treatment

Study Arms (2)

Vocal activity

EXPERIMENTAL

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

Vocal rest

EXPERIMENTAL

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

Vocal rest versus vocalization BEHAVIORAL

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

Vocal activity; Vocal rest

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

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

Study Sites (1)

LawsonHRI

London, Ontario, N6G 1H1, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: May 23, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)