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Effects of Altered Auditory Feedback on Speech Fluency

Primary Purpose

Stuttering, Adult

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Altered Auditory Feedback
Sponsored by
Massachusetts Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stuttering, Adult

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Identifies as a person who stutters Is US citizen or green card holder currently residing in the US Has one of the following Apple devices: iPhone with iOS 12.0 or later iPad with iPadOS 12.0 or later iPod touch with iOS 12.0 or later Mac with macOS 11.0 or later and an Apple M1 chip or later Has a SEPARATE browser-supporting device with a microphone Is able to conduct the study in English Qualifies based on an initial screening evaluation (Greater than 2.5% Stuttering-Like Dysfluencies per syllable) Exclusion Criteria: -

Sites / Locations

  • Massachusetts Institute of TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Altered Auditory Feedback

Arm Description

Participants in this arm will use the Mumble Melody application over the course of 1 month

Outcomes

Primary Outcome Measures

Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and the end of week 4.
Fluency change From Baseline - Week 4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants

Secondary Outcome Measures

Frequency of Mode Usage
Number of times participants use each modes per day throughout the study
Duration of Mode Usage
Length of times participants use different modes per day throughout the study
Survey data on experience using the application
A final survey provided for participants' feedback on their experience
Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and end of week 1, 2, and 3.
Fluency change From Baseline - Week 1,2,3 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Significant change in fluency in the Baseline (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.
Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Significant change in fluency in the Final (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.
Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Significant change in fluency for the Final (No Auditory Feedback) condition in comparison to the baseline (No Auditory Feedback) condition, for each testing session
Fluency change From Baseline (No Auditory Feedback) - Final (No Auditory Feedback) for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Significant change in fluency for each mode in comparison to the baseline (No Auditory Feedback) condition, for each testing session
Fluency change From Baseline (No Auditory Feedback) - each Mode for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Significant change in fluency for each non- control mode (Whisper, Reverb, Harmonize) in comparison to the control mode (Unaltered), for each testing session
Fluency change From Unaltered Mode - Whisper/Reverb/Harmonize modes for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants

Full Information

First Posted
May 9, 2023
Last Updated
August 21, 2023
Sponsor
Massachusetts Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT06011837
Brief Title
Effects of Altered Auditory Feedback on Speech Fluency
Official Title
Effects of Altered Auditory Feedback on Speech Fluency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
July 14, 2024 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
The purpose of the study is to use altered auditory vocal feedback to increase fluency in people who stutter and to examine changes in this effect over the course of a one month period occurring outside the laboratory setting.
Detailed Description
The Mumble Melody app applies voice transformations (or "modes") to a user's voice in real-time while they are speaking. The modes include Unaltered, Whisper, Reverberated, and Harmonious voice transformations. The Mumble Melody Longitudinal Study is a month-long online study in which we will be investigating the longer term effects of using the Mumble Melody app for people who stutter. During the course of a month, eligible participants will use the Mumble Melody app daily for however long, on whichever modes, and in whichever settings they wish. Additionally, we will be sending an online platform for participants to conduct weekly at-home testing sessions, in which they will be asked to record their voice during various speech tasks, both with and without the Mumble Melody app. During testing sessions, we will collect voice recordings from participants. Step 1: Participants will sign a consent form via Redcap. Participants will need an Apple device compatible with the Mumble Melody app. Step 2: Participants will receive an additional form via Redcap through which they can input information about what device they will be using for the Mumble Melody study, as well as shipping information to receive wired headphones and a headphone jack (which are necessary to use the app). Step 3: Participants conduct an initial screening session through an online platform, in which they respond to 3 90-second open questions and conduct a passage reading task. We will be collecting voice recordings as they speak within the sessions. Step 4: Participants' eligibility will be determined using the voice recordings received from step 3. The amount of stuttering-like events and total number of syllables within the recordings will determine if participants have a moderate to severe stutter, meaning they will be eligible for the study. Step 5: Eligible participants are shipped wired headphones and a headphone jack adapter Step 6: Participants will fill out an initial survey and optional OASES (Overall Assessment of the Speaker's Experience of Stuttering) assessment of through an online platform. Step 7: Participants conduct a baseline testing session. During this testing session, participants will answer survey questions, record answers to 2 90-second open response questions without using the Mumble Melody app, follow a step-by-step guide to download and set up the Mumble Melody app, record answers to 2 90-second open response for each of the 4 modes on the Mumble Melody app, and finally record answers to 2 90-second open response questions without using the Mumble Melody app. Step 8: Step 8: For the following 28 days, participants will be told to use the app as they wish. We will collect app usage logs, which provide timestamps indicating which mode was used and length of use. Participants will receive an additional monetary reward if they use the app for at least 5 minutes for 4 out of 6 days each week. Step 9: Participants conduct 4 testing sessions, one at the end of each week of the study (day 8, 15, 22, and 29). During each testing session, participants will answer survey questions, record answers to 2 90-second open response questions without using the Mumble Melody app, record answers to 2 90-second open response for each of the 4 modes on the Mumble Melody app, and finally record answers to 2 90-second open response questions without using the Mumble Melody app. Step 10: After the study, participants will be sent a final survey asking questions on their experience throughout the study and their feedback for the app.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Adult

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Altered Auditory Feedback
Arm Type
Experimental
Arm Description
Participants in this arm will use the Mumble Melody application over the course of 1 month
Intervention Type
Device
Intervention Name(s)
Altered Auditory Feedback
Other Intervention Name(s)
Musically Modulated Auditory Feedback, Mumble Melody
Intervention Description
Mumble Melody is an application that leverages Altered Auditory Feedback (AAF). During AAF, a person's speech is altered in near-real time. Mumble Melody modulates the user's voice and plays it back to them while they are speaking. Included are Unaltered (raw voice), Whisper (voiceless sound), Reverb (cathedral sound), and Harmonized (robotic sound) voice transformations.
Primary Outcome Measure Information:
Title
Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and the end of week 4.
Description
Fluency change From Baseline - Week 4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points 1-week, 2-weeks, 3-weeks, and 4-weeks
Secondary Outcome Measure Information:
Title
Frequency of Mode Usage
Description
Number of times participants use each modes per day throughout the study
Time Frame
Calculated every day for 4 weeks
Title
Duration of Mode Usage
Description
Length of times participants use different modes per day throughout the study
Time Frame
Calculated every day for 4 weeks
Title
Survey data on experience using the application
Description
A final survey provided for participants' feedback on their experience
Time Frame
immediately after the intervention
Title
Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and end of week 1, 2, and 3.
Description
Fluency change From Baseline - Week 1,2,3 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
Title
Significant change in fluency in the Baseline (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.
Description
Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
Title
Significant change in fluency in the Final (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.
Description
Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
Title
Significant change in fluency for the Final (No Auditory Feedback) condition in comparison to the baseline (No Auditory Feedback) condition, for each testing session
Description
Fluency change From Baseline (No Auditory Feedback) - Final (No Auditory Feedback) for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
Title
Significant change in fluency for each mode in comparison to the baseline (No Auditory Feedback) condition, for each testing session
Description
Fluency change From Baseline (No Auditory Feedback) - each Mode for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
Title
Significant change in fluency for each non- control mode (Whisper, Reverb, Harmonize) in comparison to the control mode (Unaltered), for each testing session
Description
Fluency change From Unaltered Mode - Whisper/Reverb/Harmonize modes for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
Time Frame
Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Identifies as a person who stutters Is US citizen or green card holder currently residing in the US Has one of the following Apple devices: iPhone with iOS 12.0 or later iPad with iPadOS 12.0 or later iPod touch with iOS 12.0 or later Mac with macOS 11.0 or later and an Apple M1 chip or later Has a SEPARATE browser-supporting device with a microphone Is able to conduct the study in English Qualifies based on an initial screening evaluation (Greater than 2.5% Stuttering-Like Dysfluencies per syllable) Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisha Kodibagkar, MS
Phone
2145973346
Email
akodiba1@mit.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Kleinberger, PhD
Email
rebklein@mit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satrajit Ghosh, PhD
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Institute of Technology
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisha Kodibagkar, MS
Phone
214-597-3346
Email
akodiba1@mit.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Kleinberger, PhD
Email
rebklein@mit.edu
First Name & Middle Initial & Last Name & Degree
Satrajit Ghosh, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Subjects can choose to consent to having their audio recordings and survey answers shared with the researchers of this study and other qualified researchers.
IPD Sharing Time Frame
Starting September 2024
IPD Sharing Access Criteria
The data will be shared through an online repository such as Dataverse, with associated data use agreement to not use the information to identify participants, and to reuse the data in a manner to verify the outcomes of the research or related research. Based on our consent form, individual data may also be submitted to databases for any broad reuse.

Learn more about this trial

Effects of Altered Auditory Feedback on Speech Fluency

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