Cochlear Hearing LossEarly Phase 1NCT05486637
Vocal Emotion Communication With Cochlear Implants
A Early Phase 1 study testing Perception of acoustic cues to emotion and Production of acoustic cues to emotion in people with Cochlear Hearing Loss, run by Father Flanagan's Boys' Home at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Perception of acoustic cues to emotion and Production of acoustic cues to emotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Prelingually deaf children with cochlear implants
- Postlingually deaf adults with cochlear implants
- Normally hearing children
- Normally hearing adults
Who cannot join
- Non-native speakers of American English
- Prelingually deaf individuals who receive cochlear implants after age 12
- Adults unable to pass a basic cognitive screen
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Northwestern University
Evanston, Illinois, 60208
Monita Chatterjee, Ph.D., monita.chatterjee@northwestern.edu
- Recruiting
House Institute Foundation
Los Angeles, California, 90017
John J Galvin, Ph.D., jgalvin@hifla.org
- Recruiting
Boys Town National Research Hospital
Omaha, Nebraska, 68131
Monita Chatterjee, Ph.D., 531-355-5069, monita.chatterjee@boystown.org
Dawna E Lewis, Ph.D., 531-355-6607, dawna.lewis@boystown.org
- Recruiting
Arizona State University
Tempe, Arizona, 85287
Xin Luo, Ph.D., 480-965-9251, xinluo@asu.edu
About this study
Official title: Perception and Production of Emotional Prosody With Cochlear Implants
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.
Read the 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.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Perception of acoustic cues to emotion, Production of acoustic cues to emotion
- Keywords
- Emotional prosody, Acoustic cues, Perception, Production, Children, Development, Cochlear Implant, Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perception of acoustic cues to emotionBehavioural
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 emotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Perception of acoustic cues to emotion; Behavioral: Production of acoustic cues to emotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal emotion recognition accuracy
Percent correct scores in vocal emotion recognition
Measured: Years 1-5
Vocal emotion recognition sensitivity
Sensitivity (d's) in vocal emotion recognition
Measured: Years 1-5
Voice pitch (fundamental frequency) of vocal productions
Voice pitch (Hz) measured from acoustic analyses of recorded speech
Measured: Years 1-5
Intensity of vocal productions
Intensity (decibel units) measured from acoustic analyses of recorded speech
Measured: Years 1-5
Duration of vocal productions
Duration (1/speaking rate) measured from acoustic analyses of recorded speech
Measured: 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
Measured: 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
Measured: Years 1-5
Secondary outcomes (1)
Reactions times (seconds) for vocal emotion identification
Time between the end of the stimulus recording and the response (button press)
Measured: Years 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, House Institute Foundation, University of Nebraska, National Institute on Deafness and Other Communication Disorders (NIDCD), Office of Behavioral and Social Sciences Research (OBSSR)
- Responsible party
- Principal investigator, Monita Chatterjee, Father Flanagan's Boys' Home
- Investigators
- Monita Chatterjee, Ph.D., Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486637
- Sponsor's protocol ID
- Prosody
- Other IDs
- R01DC019943
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 32149924Chatterjee 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.
PubMed 31632320Damm 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.
PubMed 31589545Chatterjee 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.
PubMed 25448167
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception and Production of Emotional Prosody With Cochlear Implants
- ClinicalTrials.gov ID
- NCT05486637
- Acronym / sponsor ID
- Prosody
- Conditions
- Cochlear Hearing Loss
- Keywords
- Emotional prosody, Acoustic cues, Perception, Production, Children, Development, Cochlear Implant, Hearing Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Collaborators
- Arizona State University, House Institute Foundation, University of Nebraska, National Institute on Deafness and Other Communication Disorders (NIDCD), Office of Behavioral and Social Sciences Research (OBSSR)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vocal emotion communication by children and adults with cochlear implants or normal hearing | Experimental | Behavioral: Perception of acoustic cues to emotion, Behavioral: Production of acoustic cues to emotionParticipants 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. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Prelingually deaf children with cochlear implants
Key exclusion criteria (3 listed)
- Non-native speakers of American English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perception of acoustic cues to emotionUsing 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. | Behavioural | Vocal emotion communication by children and adults with cochlear implants or normal hearing |
| Production of acoustic cues to emotionThe 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. | Behavioural | Vocal emotion communication by children and adults with cochlear implants or normal hearing |
Primary outcome
Vocal emotion recognition accuracy
Time frame: Years 1-5
Percent correct scores in vocal emotion recognition
Vocal emotion recognition sensitivity
Time frame: Years 1-5
Sensitivity (d's) in vocal emotion recognition
Voice pitch (fundamental frequency) of vocal productions
Time frame: Years 1-5
Voice pitch (Hz) measured from acoustic analyses of recorded speech
Intensity of vocal productions
Time frame: Years 1-5
Intensity (decibel units) measured from acoustic analyses of recorded speech
Duration of vocal productions
Time frame: Years 1-5
Duration (1/speaking rate) measured from acoustic analyses of recorded speech
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
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
1 secondary outcome
Reactions times (seconds) for vocal emotion identification
Time frame: Years 1-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 32149924Barrett 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.
- Background: PubMed 31632320Chatterjee 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.
- Background: PubMed 31589545Damm 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.
- Background: PubMed 25448167Chatterjee 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monita Chatterjee, Ph.D. principal investigator
Father Flanagan's Boys' Home
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Perception of acoustic cues to emotion and Production of acoustic cues to emotion in people with Cochlear Hearing Loss, run by Father Flanagan's Boys' Home at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monita Chatterjee, Ph.D. (8474672760, monita.chatterjee@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal emotion recognition accuracy (time frame: Years 1-5). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486637, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.