- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04929184
Speech Processing in Stuttering
September 21, 2023 updated by: Emily O'Dell Garnett, University of Michigan
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study team will update the record to include the secondary identification number once the NIH has released the funds.
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emily Garnett, PhD
- Phone Number: 734-232-3371
- Email: emilyog@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Emily Garnett, PhD
- Phone Number: 734-232-3371
- Email: emilyog@umich.edu
-
East Lansing, Michigan, United States, 48824
- Recruiting
- Michigan State University
-
Contact:
- Devin McAuley, PhD
- Phone Number: 517-353-9069
-
Principal Investigator:
- Devin McAuley, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adults who stutter (AWS)
Participants will have 2 visits.
|
Participants will complete speech tasks such as listening to and/or producing speech and non-speech sounds.
|
Other: Healthy Adults
Participants will have 2 visits.
|
Participants will complete speech tasks such as listening to and/or producing speech and non-speech sounds.
|
Experimental: Children who Stutter
Participants will have 1 visit.
|
Participants will complete speech tasks such as listening to and/or producing speech and non-speech sounds.
|
Other: Healthy Children
Participants will have 1 visit.
|
Participants will complete speech tasks such as listening to and/or producing speech and non-speech sounds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase locking value (PLV) - Session 1 speech tasks
Time Frame: Session 1 (up to 4 hours)
|
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 1 (up to 4 hours)
|
Phase locking value (PLV) - Session 2 speech tasks
Time Frame: Session 2 (up to 4 hours)
|
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.
|
Session 2 (up to 4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase locking value (PLV) - Non-speech tasks
Time Frame: Session 1 (up to 4 hours)
|
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.
|
Session 1 (up to 4 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emily Garnett, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2022
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 10, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00194953
- 1R21DC019429-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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