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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01315730
Other study ID # UMO-0001
Secondary ID
Status Withdrawn
Phase Phase 1
First received March 11, 2011
Last updated May 9, 2014
Start date March 2011

Study information

Verified date May 2014
Source University of Mississippi, Oxford
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.


Description:

A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences & Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults diagnosed with persistent developmental stuttering

Exclusion Criteria:

- Subjects below 18 years of age

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Tactile Stimulation
See Arms

Locations

Country Name City State
United States The University of Mississippi University Mississippi

Sponsors (4)

Lead Sponsor Collaborator
University of Mississippi, Oxford Auburn University, University of Louisiana at Lafayette, West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Snyder GJ, Blanchet P, Waddell D, Ivy LJ. Effects of digital vibrotactile speech feedback on overt stuttering frequency. Percept Mot Skills. 2009 Feb;108(1):271-80. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Fluency Speech fluency was defined by either reading or saying a set syllable sentence in a book which is normally 8th grade reading level or lower. Pauses or stutters are considered positive indicators of dis-fluent speech. 1 week No
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