Recruiting
Early Phase 1

Cochlear Implants

Sponsor:

Father Flanagan's Boys' Home

Code:

NCT05486637

Conditions

Cochlear Hearing Loss

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Interventions

Perception of acoustic cues to emotion

Production of acoustic cues to emotion

Study Details

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.

Conditions

Cochlear Hearing Loss

Study ID

NCT05486637

Start date

Jul 1, 2022

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Prelingually deaf children with cochlear implants

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

Exclusion Criteria:

  • Non-native speakers of American English

  • Prelingually deaf individuals who receive cochlear implants after age 12
  • Adults unable to pass a basic cognitive screen

Study Design

Enrollment

255 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

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.

Interventions

Perception of acoustic cues to emotion

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.

Production of acoustic cues to emotion

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.

Primary outcome measure

  • Vocal emotion recognition accuracy [ Time Frame: Years 1-5 ]
  • Vocal emotion recognition sensitivity [ Time Frame: Years 1-5 ]
  • Voice pitch (fundamental frequency) of vocal productions [ Time Frame: Years 1-5 ]
  • Intensity of vocal productions [ Time Frame: Years 1-5 ]
  • Duration of vocal productions [ Time Frame: Years 1-5 ]
  • Recognition of recorded speech emotions by listeners -- percent correct scores [ Time Frame: Years 1-5 ]
  • Recognition of recorded speech emotions by listeners -- d' values (sensitivity measure) [ Time Frame: Years 1-5 ]

Central Contacts and Locations

Central contacts

Monita Chatterjee, Ph.D.

8474672760monita.chatterjee@northwestern.edu

Dawna E Lewis, Ph.D.

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

Locations

Arizona State University

Recruiting

Tempe, Arizona, United States, 85287

Contacts

Xin Luo, Ph.D.

480-965-9251xinluo@asu.edu

House Institute Foundation

Recruiting

Los Angeles, California, United States, 90017

Contacts

John J Galvin, Ph.D.

jgalvin@hifla.org

Boys Town National Research Hospital

Recruiting

Omaha, Nebraska, United States, 68131

Contacts

Monita Chatterjee, Ph.D.

531-355-5069monita.chatterjee@boystown.org

Dawna E Lewis, Ph.D.

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

More Information

Sponsor

Father Flanagan's Boys' Home

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • Emotional prosody
  • Acoustic cues
  • Perception
  • Production
  • Children
  • Development
  • Cochlear Implant
  • Hearing Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Father Flanagan's Boys' Home on 2025-09-19.