Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-05-26
2024-07-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Altered Auditory Feedback
Participants in this arm will use the Mumble Melody application over the course of 1 month
Altered Auditory Feedback
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.
Interventions
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Altered Auditory Feedback
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Massachusetts Institute of Technology
OTHER
Responsible Party
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Principal Investigators
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Satrajit Ghosh, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology
Locations
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Massachusetts Institute of Technology
Cambridge, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1906848293
Identifier Type: -
Identifier Source: org_study_id
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