NCT05486637

Brief Summary

Patients with hearing loss who use cochlear implants (CIs) show significant deficits and strong unexplained intersubject variability in their perception and production of spoken emotions in speech. This project will investigate the hypothesis that "cue-weighting", or how patients utilize the different acoustic cues to emotion, accounts for significant variance in emotional communication with CIs. The results will focus on children with CIs, but parallel measures in postlingually deaf adults with CIs will be made, ensuring that results of these studies benefit social communication by CI patients across the lifespan by informing the development of technological innovations and improved clinical protocols.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for early_phase_1

Timeline
14mo left

Started Jul 2022

Longer than P75 for early_phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Study Progress77%
Jul 2022Jun 2027

Study Start

First participant enrolled

July 1, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

July 26, 2022

Last Update Submit

September 16, 2025

Conditions

Cochlear Hearing Loss

Keywords

Emotional prosodyAcoustic cuesPerceptionProductionChildrenDevelopmentCochlear ImplantHearing Loss

Outcome Measures

Primary Outcomes (7)

  • Vocal emotion recognition accuracy

    Percent correct scores in vocal emotion recognition

    Years 1-5

  • Vocal emotion recognition sensitivity

    Sensitivity (d's) in vocal emotion recognition

    Years 1-5

  • Voice pitch (fundamental frequency) of vocal productions

    Voice pitch (Hz) measured from acoustic analyses of recorded speech

    Years 1-5

  • Intensity of vocal productions

    Intensity (decibel units) measured from acoustic analyses of recorded speech

    Years 1-5

  • Duration of vocal productions

    Duration (1/speaking rate) measured from acoustic analyses of recorded speech

    Years 1-5

  • Recognition of recorded speech emotions by listeners -- percent correct scores

    Accuracy and associated d's (sensitivity measure) in listeners' ability to identify the emotions recorded in participants' speech

    Years 1-5

  • Recognition of recorded speech emotions by listeners -- d' values (sensitivity measure)

    Sensitivity (d's based on hit rates and false alarm rates) in listeners' ability to identify the emotions recorded in participants' speech

    Years 1-5

Secondary Outcomes (1)

  • Reactions times (seconds) for vocal emotion identification

    Years 1-5

Study Arms (1)

Vocal emotion communication by children and adults with cochlear implants or normal hearing

EXPERIMENTAL

Participants will be native speakers of American English and include pediatric cochlear implant recipients with unilateral or bilateral devices aged 6-19 years, children with normal hearing aged 6-19 years, postlingually deaf adults with cochlear implants, and adults with normal hearing. In Aim 1 participants will listen to emotional speech sounds and identify the talker's intended emotion. In Aim 2 participants will be invited to produce emotional speech by reading out scripted materials or in a more naturalistic conversational setting.

Behavioral: Perception of acoustic cues to emotionBehavioral: Production of acoustic cues to emotion

Interventions

Perception of acoustic cues to emotionBEHAVIORAL

Using novel methodologies and stimuli comprising both controlled laboratory recordings and materials culled from databases of ecologically valid speech emotions (e.g., from publicly available podcasts), the team aims to collect perceptual data to build a statistical model to test the hypothesis that experience-based changes in emotion identification by pediatric and adult CI recipients is mediated by improvements in cue-optimization.

Vocal emotion communication by children and adults with cochlear implants or normal hearing
Production of acoustic cues to emotionBEHAVIORAL

The team will acoustically analyze vocal emotion productions by participants, quantify acoustic features of spoken emotions, and obtain behavioral measures of how well normally hearing listeners can identify those emotions.

Vocal emotion communication by children and adults with cochlear implants or normal hearing

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prelingually deaf children with cochlear implants
  • Postlingually deaf adults with cochlear implants
  • Normally hearing children
  • Normally hearing adults

You may not qualify if:

  • Non-native speakers of American English
  • Prelingually deaf individuals who receive cochlear implants after age 12
  • Adults unable to pass a basic cognitive screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona State University

Tempe, Arizona, 85287, United States

RECRUITING

House Institute Foundation

Los Angeles, California, 90017, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

NOT YET RECRUITING

Boys Town National Research Hospital

Omaha, Nebraska, 68131, United States

RECRUITING

Related Publications (4)

  • Barrett KC, Chatterjee M, Caldwell MT, Deroche MLD, Jiradejvong P, Kulkarni AM, Limb CJ. Perception of Child-Directed Versus Adult-Directed Emotional Speech in Pediatric Cochlear Implant Users. Ear Hear. 2020 Sep/Oct;41(5):1372-1382. doi: 10.1097/AUD.0000000000000862.

    PMID: 32149924BACKGROUND

  • Chatterjee M, Kulkarni AM, Siddiqui RM, Christensen JA, Hozan M, Sis JL, Damm SA. Acoustics of Emotional Prosody Produced by Prelingually Deaf Children With Cochlear Implants. Front Psychol. 2019 Sep 30;10:2190. doi: 10.3389/fpsyg.2019.02190. eCollection 2019.

    PMID: 31632320BACKGROUND

  • Damm SA, Sis JL, Kulkarni AM, Chatterjee M. How Vocal Emotions Produced by Children With Cochlear Implants Are Perceived by Their Hearing Peers. J Speech Lang Hear Res. 2019 Oct 25;62(10):3728-3740. doi: 10.1044/2019_JSLHR-S-18-0497. Epub 2019 Oct 7.

    PMID: 31589545BACKGROUND

  • Chatterjee M, Zion DJ, Deroche ML, Burianek BA, Limb CJ, Goren AP, Kulkarni AM, Christensen JA. Voice emotion recognition by cochlear-implanted children and their normally-hearing peers. Hear Res. 2015 Apr;322:151-62. doi: 10.1016/j.heares.2014.10.003. Epub 2014 Oct 16.

    PMID: 25448167BACKGROUND

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Monita Chatterjee, Ph.D.

    Father Flanagan's Boys' Home

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monita Chatterjee, Ph.D.

CONTACT

8474672760monita.chatterjee@northwestern.edu

Dawna E Lewis, Ph.D.

CONTACT

531-355-6607dawna.lewis@boystown.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
No masking is involved.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This is a prospective design involving human subjects who are children and adults with cochlear implants or with normal hearing. Participants will perform two kinds of tasks: 1) listening tasks in which participants listen to speech or nonspeech sounds and make a judgment regarding the emotion in the sound and 2) speaking tasks, in which participants will read aloud a list of simple sentences in a happy way and a sad way or converse with a member of the research team, in which participants retell a picture book story or describe an activity of their choosing. Participants' speech will be recorded, analyzed for its acoustics, and also used as stimuli for listening tasks. Child participants will also be invited to perform tests of cognition, vocabulary, and theory of mind. All participants will be invited to participate in all studies, with no assignment. The order of tests will be randomized as appropriate to avoid order effects.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 3, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The team plans to potentially share relevant information regarding participant age, device (if cochlear implant user), age at implantation, outcome measures, etc., excluding all PHI (personal health identifier) information.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
When specific studies are completed and published, data will be shared within 6 months post-publication.
Access Criteria
Data will be shared via Boys Town's Open Science Framework

Locations

US(4)