NCT06011837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2024

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

May 9, 2023

Last Update Submit

August 21, 2023

Conditions

Stuttering, Adult

Outcome Measures

Primary Outcomes (1)

  • 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

    Calculated at the end of the study for time points 1-week, 2-weeks, 3-weeks, and 4-weeks

Secondary Outcomes (9)

  • Frequency of Mode Usage

    Calculated every day for 4 weeks

  • Duration of Mode Usage

    Calculated every day for 4 weeks

  • Survey data on experience using the application

    immediately after the intervention

  • 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.

    Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks

  • Significant change in fluency in the Baseline (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.

    Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks

  • +4 more secondary outcomes

Study Arms (1)

Altered Auditory Feedback

EXPERIMENTAL

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

Device: Altered Auditory Feedback

Interventions

Altered Auditory FeedbackDEVICE

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.

Also known as: Musically Modulated Auditory Feedback, Mumble Melody
Altered Auditory Feedback

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

RECRUITING

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Satrajit Ghosh, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisha Kodibagkar, MS

CONTACT

2145973346akodiba1@mit.edu

Rebecca Kleinberger, PhD

CONTACT

rebklein@mit.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

August 25, 2023

Study Start

May 26, 2023

Primary Completion

July 14, 2024

Study Completion

July 14, 2024

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Subjects can choose to consent to having their audio recordings and survey answers shared with the researchers of this study and other qualified researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting September 2024
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.

Locations

US(1)