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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Spasmodic Dysphonia; Laryngeal Dystonia

Detailed 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

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with spasmodic dysphonia are eligible for this study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Office of Rare Diseases (ORD)
• Investigators: Principal Investigator: Christy Ludlow, PhD, James Madison University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Dystonia; Spasmodic dysphonia; Laryngeal dystonia; Severity
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Otorhinolaryngologic Diseases; Movement Disorders; Dyskinesias; Signs and Symptoms, Respiratory; Laryngeal Diseases; Voice Disorders; Dystonia; Dystonic Disorders; Dysphonia; Hoarseness
• Other Study ID Numbers: IRB00068259; U54NS065701 (U.S. NIH Grant/Contract)