Clinical trial NCT02061943: Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change
Official title: Validity and Reliability of the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Quantifying Symptom Change
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spasmodic Dysphonia
Laryngeal Dystonia
Keywords: Spasmodic dysphonia
Laryngeal dystonia
Dystonia
Severity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Office of Rare Diseases (ORD)
First posted: 2014-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with spasmodic dysphonia are eligible for this study.

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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: SD-DAP
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: James Madison University
name: Christy Ludlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: