Spasmodic DysphoniaNCT02061943
Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change
An observational study of Spasmodic Dysphonia and Laryngeal Dystonia, run by Emory University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spasmodic Dysphonia, Laryngeal Dystonia
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with spasmodic dysphonia are eligible for this study.
Who may be able to join
- be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia)
- be 18 years of age or older
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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
- Conditions
- Spasmodic Dysphonia, Laryngeal Dystonia
- Keywords
- Spasmodic dysphonia, Laryngeal dystonia, Dystonia, Severity
- Medical subject headings
- Dysphonia, Dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
SD-DAP
Identify items within the SD-DAP that are sensitive to symptom reduction when participants with spasmodic dysphonia are treated with botulinum toxin.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startOct 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasmodic DysphoniaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD)
- Responsible party
- Principal investigator, Hyder A. Jinnah, MD, PhD, Emory University
- Investigators
- Christy Ludlow, PhD, Principal investigator, James Madison University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061943
- Sponsor's protocol ID
- IRB00068259
- Other IDs
- U54NS065701
- Status last verified
- May 2016
- First submitted
- 11 Feb 2014
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Quantifying Symptom Change
- ClinicalTrials.gov ID
- NCT02061943
- Acronym / sponsor ID
- IRB00068259
- Conditions
- Spasmodic Dysphonia, Laryngeal Dystonia
- Keywords
- Spasmodic dysphonia, Laryngeal dystonia, Dystonia, Severity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with spasmodic dysphonia are eligible for this study.
Key inclusion criteria (2 listed)
- be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia)
- be 18 years of age or older
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy Ludlow, PhD principal investigator
James Madison University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasmodic Dysphonia and Laryngeal Dystonia, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SD-DAP (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.