Speech Processing in Stuttering
Primary Purpose
Stuttering, Stuttering, Childhood, Stuttering, Adult
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech and non-speech tasks
Sponsored by
About this trial
This is an interventional basic science trial for Stuttering focused on measuring Healthy children, Healthy Adults
Eligibility Criteria
Inclusion Criteria (adults who do not stutter):
- 18-65 years old
- English as primary language
- Normal speech, language, hearing, cognition
Exclusion criteria: (adults who do not stutter)
- Personal or family history of stuttering
- Major medical or psychiatric illness
Inclusion criteria: (adults who stutter)
- Aged 18-65 years
- English as primary language
- Normal speech, language, hearing, cognition (other than stuttering)
- Currently stutters
Exclusion criteria: (adults who stutter)
- Speech therapy within the past year
- Major medical or psychiatric illness
Inclusion criteria: (children who do not stutter)
- Aged 6 to 17 years
- English as primary language
- Normal speech, language, hearing, cognition
Exclusion criteria: (children who do not stutter)
- Personal or family history of stuttering
- Major medical or psychiatric illness
- Language/motor delay
Inclusion criteria: (children who stutter)
- Aged 6 to 17 years
- English as primary language
- Normal speech, language, hearing, cognition (other than stuttering)
- Currently stutters
Exclusion criteria: (children who stutter)
- Major medical or psychiatric illness
- Language/motor delay
Sites / Locations
- University of MichiganRecruiting
- Michigan State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
Adults who stutter (AWS)
Healthy Adults
Children who Stutter
Healthy Children
Arm Description
Participants will have 2 visits.
Participants will have 2 visits.
Participants will have 1 visit.
Participants will have 1 visit.
Outcomes
Primary Outcome Measures
Phase locking value (PLV) - Session 1 speech tasks
The degree of synchronization will be measured by computing the PLV between subject's produced speech and the heard speech. The PLV is a vector with a value between 0 and 1 that reflects the phase difference between two signals.
Phase locking value (PLV) - Session 2 speech tasks
The degree of synchronization will be measured by computing the PLV between subject's produced speech and the heard speech. The PLV is a vector with a value between 0 and 1 that reflects the phase difference between two signals. Session 2 is for adults only.
Secondary Outcome Measures
Phase locking value (PLV) - Non-speech tasks
The degree of synchronization will be measured by computing the PLV between subject's produced response and the auditorily presented stimuli. The PLV is a vector with a value between 0 and 1 that reflects the phase difference between two signals.
Full Information
NCT ID
NCT04929184
First Posted
June 10, 2021
Last Updated
September 21, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT04929184
Brief Title
Speech Processing in Stuttering
Official Title
Speech Processing in Stuttering
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This research is being done to better understand stuttering, specifically how people who stutter may process and/or produce speech. Eligible participants enrolled will complete a variety of computer and speech-based tasks on up to 2 visits.
Detailed Description
The study team will update the record to include the secondary identification number once the NIH has released the funds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Stuttering, Childhood, Stuttering, Adult
Keywords
Healthy children, Healthy Adults
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adults who stutter (AWS)
Arm Type
Experimental
Arm Description
Participants will have 2 visits.
Arm Title
Healthy Adults
Arm Type
Other
Arm Description
Participants will have 2 visits.
Arm Title
Children who Stutter
Arm Type
Experimental
Arm Description
Participants will have 1 visit.
Arm Title
Healthy Children
Arm Type
Other
Arm Description
Participants will have 1 visit.
Intervention Type
Behavioral
Intervention Name(s)
Speech and non-speech tasks
Intervention Description
Participants will complete speech tasks such as listening to and/or producing speech and non-speech sounds.
Primary Outcome Measure Information:
Title
Phase locking value (PLV) - Session 1 speech tasks
Description
The degree of synchronization will be measured by computing the PLV between subject's produced speech and the heard speech. The PLV is a vector with a value between 0 and 1 that reflects the phase difference between two signals.
Time Frame
Session 1 (up to 4 hours)
Title
Phase locking value (PLV) - Session 2 speech tasks
Description
The degree of synchronization will be measured by computing the PLV between subject's produced speech and the heard speech. The PLV is a vector with a value between 0 and 1 that reflects the phase difference between two signals. Session 2 is for adults only.
Time Frame
Session 2 (up to 4 hours)
Secondary Outcome Measure Information:
Title
Phase locking value (PLV) - Non-speech tasks
Description
The degree of synchronization will be measured by computing the PLV between subject's produced response and the auditorily presented stimuli. The PLV is a vector with a value between 0 and 1 that reflects the phase difference between two signals.
Time Frame
Session 1 (up to 4 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (adults who do not stutter):
18-65 years old
English as primary language
Normal speech, language, hearing, cognition
Exclusion criteria: (adults who do not stutter)
Personal or family history of stuttering
Major medical or psychiatric illness
Inclusion criteria: (adults who stutter)
Aged 18-65 years
English as primary language
Normal speech, language, hearing, cognition (other than stuttering)
Currently stutters
Exclusion criteria: (adults who stutter)
Speech therapy within the past year
Major medical or psychiatric illness
Inclusion criteria: (children who do not stutter)
Aged 6 to 17 years
English as primary language
Normal speech, language, hearing, cognition
Exclusion criteria: (children who do not stutter)
Personal or family history of stuttering
Major medical or psychiatric illness
Language/motor delay
Inclusion criteria: (children who stutter)
Aged 6 to 17 years
English as primary language
Normal speech, language, hearing, cognition (other than stuttering)
Currently stutters
Exclusion criteria: (children who stutter)
Major medical or psychiatric illness
Language/motor delay
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Garnett, PhD
Phone
734-232-3371
Email
emilyog@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Garnett, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Garnett, PhD
Phone
734-232-3371
Email
emilyog@umich.edu
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devin McAuley, PhD
Phone
517-353-9069
First Name & Middle Initial & Last Name & Degree
Devin McAuley, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Speech Processing in Stuttering
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