Sensorineural Hearing LossNCT05634356
Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning
A study testing vocal-social reinforcement in people with Sensorineural Hearing Loss and Speech, run by University of Southern California at 1 site in United States.
Trial summary
The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from ~7-18 months. Infants have either typical hearing or sensorineural hearing loss. Read more about this study
- Who is it for?
- Ages 7 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss, Speech
- What is being tested?
- vocal-social reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants ca. 7-16 months of age at study onset
- Infants less than 24 months of age (for follow-up visits only)
- At least one English-speaking or Spanish-speaking parent in the home who can participate in the study
- Subjects will include infants with typical hearing, hearing loss, or hearing loss remediated by a hearing aid or cochlear implant.
Who cannot join
- infants who are not exposed to English or Spanish in the home
- infants who do not have a parent who can participate in the study will be excluded (Caregivers who are not parents will not be eligible to participate in the study)
Trial locations and contacts
1 site in 1 country.
Martin Nunez Rivera, B.S. contact
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Sarah W Bottjer, Ph.D., 213-740-9183, bottjer@usc.edu
About this study
The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from ~7-18 months. Infants have either typical hearing or sensorineural hearing loss. The main prediction of the study is that social reinforcement will engender improvements in vocal learning above and beyond gains in hearing in infants with hearing loss. As part of this study:
- The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words;
- Infants hear playback of the same words during a second phase.
Read the detailed description
Infant vocal learning and development is embedded in a social feedback loop. Babbling vocalizations catalyze consistent responding by caregivers, and these predictable social reactions provide opportunities for infant learning. Naturalistic data and experimental manipulations have verified both the potency of babbling for eliciting social-vocal responses from caregivers, and the efficacy of social feedback for rapid advances in infant vocal learning. The impact of infant hearing loss, however, has never been studied with regard to the social feedback loop. Infants born with significant sensorineural hearing loss may be deprived not only of early auditory experience but of social experience as well. The reduction or elimination of social feedback to immature vocalizations, either by reduced or unpredictable parental responses or by infants' lessened ability to perceive those responses, is likely to have strong effects on learning and development of speech. Restoring hearing via cochlear implants improves auditory perception but does not remediate lost social learning opportunities or provide knowledge of how to learn from social partners. The goal of this project is to investigate how social interactions mediate the ability to incorporate phonological patterns of the language environment into vocal repertoires in infants with typical hearing versus infants with hearing loss (who either continue with hearing aids or experience gains in hearing via receipt of a cochlear implant). The investigators' method is to remotely observe naturally-occurring interactions between infants and a parent while recording their vocalizations; the investigators instruct the parent via headphones to provide vocal-social reinforcement to the infants when they produce a babbling utterance. Infant-parent dyads in a yoked control condition receive the same schedule of social reinforcement cues as a matched pair, which is random with respect to actual infant utterances in the control condition.
- Conditions
- Sensorineural Hearing Loss, Speech
- Being tested
- vocal-social reinforcement
- Medical subject headings
- Hearing Loss, Sensorineural, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vocal-social reinforcementBehavioural
experimental manipulation of social reinforcement in response to vocalizations
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Parents are instructed to say nonsense words in response to infant babbles with a conserved phonological form as infant plays. Receives: Behavioral: vocal-social reinforcement |
| Control | No intervention | Parents are instructed to say nonsense words at random times with a conserved phonological form as infant plays. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vocal Codes During Study Visit
Infant vocalizations are assigned to categories of speech maturity, and frequency of each category will be assessed before, during, and after the cued responses from parents.
Measured: Measured over the course of 30 minutes
Secondary outcomes (3)
Change in Vocal Codes Between Visits
The same categories of speech maturity will be used at each study visit, allowing comparison of speech composition over time.
Measured: Measured at initial visit and up to three additional times between 30-180 days following the initial visit
Perception
Infants will hear a recording of the same nonsense words spoken by their parent, and investigators will measure how long the infant looks in the direction of the word (how long the infant pays attention to each word).
Measured: Measured at initial visit and up to three additional times between 30-180 days following the initial visit
MacArthur Communicative Development Inventory
This vocabulary inventory form will measure the breadth of the infant's known words and early sentence use.
Measured: assessed at 16 months and/or 6 months after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start12 Oct 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have a parallel design in which parent-infant dyads are assigned to either the intervention or to a random control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Sarah Bottjer, University of Southern California
- Investigators
- Sarah W Bottjer, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634356
- Sponsor's protocol ID
- UP-18-00666
- Other IDs
- 1R21DC019773
- Status last verified
- Jun 2024
- First submitted
- 4 Nov 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning
- ClinicalTrials.gov ID
- NCT05634356
- Acronym / sponsor ID
- UP-18-00666
- Conditions
- Sensorineural Hearing Loss, Speech
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Cornell University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 2 Dec 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.
The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from ~7-18 months. Infants have either typical hearing or sensorineural hearing loss. The main prediction of the study is that social reinforcement will engender improvements in vocal learning above and beyond gains in hearing in infants with hearing loss. As part of this study:
- The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words;
- Infants hear playback of the same words during a second phase.
Detailed description
Infant vocal learning and development is embedded in a social feedback loop. Babbling vocalizations catalyze consistent responding by caregivers, and these predictable social reactions provide opportunities for infant learning. Naturalistic data and experimental manipulations have verified both the potency of babbling for eliciting social-vocal responses from caregivers, and the efficacy of social feedback for rapid advances in infant vocal learning. The impact of infant hearing loss, however, has never been studied with regard to the social feedback loop. Infants born with significant sensorineural hearing loss may be deprived not only of early auditory experience but of social experience as well. The reduction or elimination of social feedback to immature vocalizations, either by reduced or unpredictable parental responses or by infants' lessened ability to perceive those responses, is likely to have strong effects on learning and development of speech. Restoring hearing via cochlear implants improves auditory perception but does not remediate lost social learning opportunities or provide knowledge of how to learn from social partners. The goal of this project is to investigate how social interactions mediate the ability to incorporate phonological patterns of the language environment into vocal repertoires in infants with typical hearing versus infants with hearing loss (who either continue with hearing aids or experience gains in hearing via receipt of a cochlear implant). The investigators' method is to remotely observe naturally-occurring interactions between infants and a parent while recording their vocalizations; the investigators instruct the parent via headphones to provide vocal-social reinforcement to the infants when they produce a babbling utterance. Infant-parent dyads in a yoked control condition receive the same schedule of social reinforcement cues as a matched pair, which is random with respect to actual infant utterances in the control condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We have a parallel design in which parent-infant dyads are assigned to either the intervention or to a random control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: vocal-social reinforcementParents are instructed to say nonsense words in response to infant babbles with a conserved phonological form as infant plays. |
| Control | No intervention | –Parents are instructed to say nonsense words at random times with a conserved phonological form as infant plays. |
Who may qualify
- Ages
- 7 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- infants ca. 7-16 months of age at study onset
- Infants less than 24 months of age (for follow-up visits only)
- At least one English-speaking or Spanish-speaking parent in the home who can participate in the study
- Subjects will include infants with typical hearing, hearing loss, or hearing loss remediated by a hearing aid or cochlear implant.
Key exclusion criteria (2 listed)
- infants who are not exposed to English or Spanish in the home
- infants who do not have a parent who can participate in the study will be excluded (Caregivers who are not parents will not be eligible to participate in the study)
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 |
|---|---|---|
| vocal-social reinforcementexperimental manipulation of social reinforcement in response to vocalizations | Behavioural | Experimental |
Primary outcome
Change in Vocal Codes During Study Visit
Time frame: Measured over the course of 30 minutes
Infant vocalizations are assigned to categories of speech maturity, and frequency of each category will be assessed before, during, and after the cued responses from parents.
3 secondary outcomes
Change in Vocal Codes Between Visits
Time frame: Measured at initial visit and up to three additional times between 30-180 days following the initial visit
Perception
Time frame: Measured at initial visit and up to three additional times between 30-180 days following the initial visit
MacArthur Communicative Development Inventory
Time frame: assessed at 16 months and/or 6 months after initial visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Sensorineural Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
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. This study is not recruiting at the moment.
Martin Nunez Rivera, B.S. contact
Sarah W Bottjer, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vocal-social reinforcement in people with Sensorineural Hearing Loss and Speech, run by University of Southern California at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah W Bottjer, Ph.D. (213-740-9183, bottjer@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vocal Codes During Study Visit (time frame: Measured over the course of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2024.