- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04929184
Speech Processing in Stuttering
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
East Lansing, Michigan, United States, 48824
- Michigan State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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)
|
Participants will hear a series of single syllables spoken rhythmically and will be instructed to whisper the syllable "tah" repeatedly while the recording is playing. The degree of synchronization (how well the participant's whispered syllables match the cadence of the recorded syllables they are listening to) 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, where 0 is a complete mis-match and a 1 is a perfect match. Adults were not instructed to attempt to match the cadence (Implicit task). Child participants were instructed to attempt to match the cadence (Explicit task). |
Session 1 (up to 4 hours)
|
|
Phase Locking Value (PLV) - Session 2 Speech Tasks
Time Frame: Session 2 (up to 4 hours)
|
Adult participants will hear a series of single syllables spoken rhythmically and will be instructed to whisper the syllable "tah" repeatedly while the recording is playing. Child participants did not attend Session 2. The degree of synchronization (how well the participant's whispered syllables match the cadence of the recorded syllables they are listening to) 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, where 0 is a complete mis-match and a 1 is a perfect match. Adults completed this task twice. For the first test, they were not instructed to attempt to match the cadence (Implicit task). For the second test, they were instructed to attempt to match the cadence (Explicit task). |
Session 2 (up to 4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
R Statistic (Resultant Vector Length)
Time Frame: Session 1 (up to 4 hours)
|
In tapping synchronization (sensorimotor synchronization) research, the R statistic generally refers to the resultant vector length derived from circular statistics, used to quantify the consistency and stability of a participant's tapping relative to a rhythmic stimulus.
It ranges from 0 to 1. 0=Complete inconsistency (taps are uniformly distributed).
1=Perfect consistency (all taps occur at the exact same relative phase).
|
Session 1 (up to 4 hours)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily Garnett, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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