Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | September 2017 |
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.
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.
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
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
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)
We found this trial at
2
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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