Examining the Spasmodic Dysphonia Diagnosis and Assessmen... | NCT02061943

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

NCT02061943

Sponsor

Emory University

Status

Withdrawn

Last Update Posted

May 30, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Spasmodic Dysphonia
Laryngeal Dystonia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U54NS065701	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study not started

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Apr 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Feb 11, 2014

First Submission Date that Met QC Criteria

Feb 11, 2014

First Posted Date

Feb 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2016

Last Update Posted Date

May 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH
Office of Rare Diseases (ORD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

People with spasmodic dysphonia are eligible for this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christy Ludlow, PhD	James Madison University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30322	United States
Washington University in St. Louis

Condition Browse Module

MeSH Terms

ID	Term
D055154	Dysphonia
D004421	Dystonia

Ancestor Terms

ID	Term
D014832	Voice Disorders
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided