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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061943
Recruitment Status : Withdrawn (Study not started)
First Posted : February 13, 2014
Last Update Posted : May 30, 2016
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Information provided by (Responsible Party):
Hyder A. Jinnah, MD, PhD, Emory University

Brief 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.

Condition or disease
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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validity and Reliability of the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Quantifying Symptom Change
Study Start Date : October 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Primary Outcome Measures :
  1. SD-DAP [ Time Frame: 2-4 weeks ]
    Identify items within the SD-DAP that are sensitive to symptom reduction when participants with spasmodic dysphonia are treated with botulinum toxin.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with spasmodic dysphonia are eligible for this study.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061943

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
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Principal Investigator: Christy Ludlow, PhD James Madison University
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Responsible Party: Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University Identifier: NCT02061943    
Other Study ID Numbers: IRB00068259
U54NS065701 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Keywords provided by Hyder A. Jinnah, MD, PhD, Emory University:
Spasmodic dysphonia
Laryngeal dystonia
Additional relevant MeSH terms:
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Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory