Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change

Spasmodic Dysphonia Clinical Trial

Official title:

Validity and Reliability of the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Quantifying Symptom Change

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02061943
• Other study ID #: IRB00068259
• Secondary ID: U54NS065701
• Status: Withdrawn
• Phase: N/A
• First received: February 11, 2014
• Last updated: May 27, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a study of patients with spasmodic dysphonia to determine how best to measure the severity of the disorder in patients. It addresses which characteristics of speech are the best indicator of whether or not a particular treatment has benefited a person with spasmodic dysphonia. We hope to recruit 20 participants each at 2 different centers. The evaluation for each participant will be done on a two visits, one just before and another several weeks after treatment.

Description:

This is a study of changes in voice and laryngeal function with treatment recorded using the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP). Persons with adductor spasmodic dysphonia will complete a questionnaire on the Voice Handicap Index (VHI) and ratings of speech effort as well as have their speech recorded and receive a nasolaryngoscopy examination prior to their usual treatment with botulinum toxin injection into the laryngeal muscles for their voice disorder. They will return for re-examination several weeks later after their injection and repeat each of the examinations. The purpose is to determine which items on the SD-DAP are sensitive to changes in the severity of their voice disorder. The items that show sensitivity would be those that would be useful for assessing voice outcomes in clinical trials. Some of the questions this study is trying to answer are

• What is the best way to measure the severity of spasmodic dysphonia?

• How does treatment of spasmodic dysphonia by botulinum toxin injection affect voice for communication in regular daily life in spasmodic dysphonia

• Is change in speaking effort related to the change in severity of spasmodic dysphonia with botulinum toxin injection?

Each participant in this study will be asked to do the following:

• Provide a copy of medical records and medical history relating to the diagnosis of spasmodic dysphonia.

• Have an examination by an otolaryngologist with a medical periscope inserted in the throat to view the voice box in action. The examination will be so it can be reviewed later by several different experts.

• Complete questionnaires regarding the severity of their disorder before and after receiving their usual treatment; an injection of botulinum toxin into the laryngeal muscles.

• Repeat a speech recording and laryngeal examination before and after treatment

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia)

• be 18 years of age or older

Exclusion Criteria:

• be diagnosed with secondary spasmodic dysphonia (laryngeal dystonia)

• be younger than 18 years of age

• unable to complete questionnaires

• not able to have a nasolaryngoscopy (examination of the voice box with a medical periscope)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dysphonia
• Dystonia
• Hoarseness
• Laryngeal Dystonia
• Spasmodic Dysphonia

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Washington University in St. Louis	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SD-DAP	Identify items within the SD-DAP that are sensitive to symptom reduction when participants with spasmodic dysphonia are treated with botulinum toxin.	2-4 weeks	No