Effects of Vocal Exercises for Spasmodic Dysphonia

NCT03349086 | Completed

• 1 other identifier: 2013-1746
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following Botox injections for adductor spasmodic dysphonia.

Conditions

Adductor Spasmodic Dysphonia

Keywords

Botox Injection; Spasmodic; Dysphonia; Voice Therapy; Speech Therapy; Voice Rest

Outcome Measures

Primary Outcomes (1)

• A quantifiable difference between the effects of voice exercise vs. voice rest post Adductor Spasmodic Dysphonia botox treatment through analysis of the Voice Handicap Index Questionnaire.

  Pre randomized condition and post 6 week and 12 week, participants will be asked to complete the Voice Handicap Index (VHI). The VHI Questionnaire (Voice Handicap Index) is a 30-item questionnaire divided into 3 subsections (Functional, Physical, Emotional) and a Total which measures the effect of voice problems on quality of life. Individuals mark each item on this 30-item questionnaire on a scale from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered Normal, 12-28 is considered Mild Minimal handicap, 29-56 is considered Moderate Handicap, and 57-120 is considered severe handicap.

  Assessing the change of the post VHI questionnaire between groups. Data will be reported at study completion, an average of 1 year.

Study Arms (2)

Voice Exercise

ACTIVE COMPARATOR

Randomized participants in this group will undergo 45 minutes of voice exercise, including sustained pitches and pitch glides on a variety of different vocal facilitators.

Behavioral: Voice Exercise

Voice Rest

NO INTERVENTION

Randomized participants in this group will undergo 45 minutes of voice rest.

Interventions

Voice Exercise BEHAVIORAL

Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.

Voice Exercise

Eligibility Criteria

• Age: 21 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• age
• Diagnosed with pure adductor spasmodic dysphonia
• Completed 2 consecutive standard of care Botox injection into the thyroarytenoid (TA) and/or thyroarytenoid/lateral cricoarytenoid (TA/LCA) junction with the same dosage

You may not qualify if:

• Receiving Botox to other laryngeal or supraglottic musculature
• Other neuro-laryngological conditions
• Those with an average of less than two injections per year

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Dysphonia; Communication Disorders

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Brienne Ruel, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo one of two study conditions immediately following a standard of care Botox injections. One condition is a 45 minute voice rest condition and the other condition is a 45 minute voice exercise condition.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: November 21, 2017
• Study Start: July 28, 2014
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)