- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05486637
Vocal Emotion Communication With Cochlear Implants
Perception and Production of Emotional Prosody With Cochlear Implants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Emotion communication is a fundamental part of spoken language. For patients with hearing loss who use cochlear implants (CIs), detecting emotions in speech poses a significant challenge. Deficits in vocal emotion perception observed in both children and adults with CIs have been linked with poor self-reported quality of life. For young children, learning to identify others' emotions and express one's own emotions is a fundamental aspect of social development. Yet, little is known about the mechanisms and factors that shape vocal emotion communication by children with CIs. Primary cues to vocal emotions (voice characteristics such as pitch) are degraded in CI hearing, but secondary cues such as duration and intensity remain accessible to patients. It is proposed that individual CI users' auditory experience with their device plays an important role in how they utilize these different cues and map them to corresponding emotions.
In previous studies, the Principal Investigator (PI) and the PI's team conducted foundational research that provided valuable information about key predictors of vocal emotion perception and production by pediatric CI recipients. The work proposed here will use novel methodologies to investigate how the specific acoustic cues used in emotion recognition by CI patients change with increasing device experience (Aim 1) and how the specific cues emphasized in vocal emotion productions by CI patients change with increasing device experience (Aim 2). Studies will include both a cross-sectional and a longitudinal approach.
The team's long-term goal is to improve emotional communication by CI users. The overall objectives of this application are to address critical gaps in knowledge by elucidating how cue-utilization (the reliance on different acoustic cues) for vocal emotion perception (Aim 1) and production (Aim 2) are shaped by CI experience. The knowledge gained from these studies will provide the evidence-base to support the development of clinical protocols that support emotional communication by pediatric CI recipients, and will thus benefit quality of life for CI users.
The hypotheses to be tested are: [H1] that cue-weighting accounts significantly for inter-subject variations in vocal emotion identification by CI users; [H2] that optimization of cue-weighting patterns is the mechanism by which predictors such as the duration of device experience and age at implantation benefit vocal emotion identification; and [H3] that in children with CIs, the ability to utilize voice pitch cues to emotion, together with early auditory experience (e.g., age at implantation and/or presence of usable hearing at birth) account significantly for inter-subject variation in emotional productions. The two Specific Aims will test these hypotheses while taking into account other factors such as cognitive and socioeconomic status, theory of mind, and psychophysical sensitivity to individual prosodic cues.
This is a prospective design involving human subjects who are children and adults. The participants will perform two kinds of tasks: 1) listening tasks in which participants listen to speech or nonspeech sounds and make a judgment about it, interacting with a software program on a computer screen; 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. In addition to these tasks, participants will also be invited to perform tests of cognition, vocabulary, and theory of mind.
Participants will not be assigned to groups, and no control group will be assigned, in any of the Aims. In parallel with cochlear implant patients, the team will test normally hearing listeners spanning a similar age range to provide information on how the intact auditory system processes emotional cues in speech in perception and in production. Effects of patient factors such as their hearing history, experience with their cochlear implant, and cognition will be investigated using regression-based models. All patients will be invited to participate in all studies, with no assignment, until the sample size target is met for the particular study. The order of tests will be randomized as appropriate to avoid order effects.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Monita Chatterjee, Ph.D.
- Phone Number: 531-355-5069
- Email: monita.chatterjee@boystown.org
Study Contact Backup
- Name: Dawna E Lewis, Ph.D.
- Phone Number: 531-355-6607
- Email: dawna.lewis@boystown.org
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85287
- Not yet recruiting
- Arizona State University
-
Contact:
- Xin Luo, Ph.D.
- Phone Number: 480-965-9251
- Email: xinluo@asu.edu
-
-
Nebraska
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Omaha, Nebraska, United States, 68131
- Recruiting
- Boys Town National Research Hospital
-
Contact:
- Monita Chatterjee, Ph.D.
- Phone Number: 531-355-5069
- Email: monita.chatterjee@boystown.org
-
Contact:
- Dawna E Lewis, Ph.D.
- Phone Number: 531-355-6607
- Email: dawna.lewis@boystown.org
-
Sub-Investigator:
- Sophie E Ambrose, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vocal emotion recognition accuracy
Time Frame: Years 1-5
|
Percent correct scores in vocal emotion recognition
|
Years 1-5
|
Vocal emotion recognition sensitivity
Time Frame: Years 1-5
|
Sensitivity (d's) in vocal emotion recognition
|
Years 1-5
|
Duration of vocal productions
Time Frame: Years 1-5
|
Duration (1/speaking rate) measured from acoustic analyses of recorded speech
|
Years 1-5
|
Voice pitch (fundamental frequency) of vocal productions
Time Frame: Years 1-5
|
Voice pitch (Hz) measured from acoustic analyses of recorded speech
|
Years 1-5
|
Intensity of vocal productions
Time Frame: Years 1-5
|
Intensity (decibel units) measured from acoustic analyses of recorded speech
|
Years 1-5
|
Recognition of recorded speech emotions by listeners -- percent correct scores
Time Frame: Years 1-5
|
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)
Time Frame: Years 1-5
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reactions times (seconds) for vocal emotion identification
Time Frame: Years 1-5
|
Time between the end of the stimulus recording and the response (button press)
|
Years 1-5
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Monita Chatterjee, Ph.D., Father Flanagan's Boys' Home
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prosody
- R01DC019943 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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