Hearing Impaired ChildrenNCT06317493
Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment
An observational study of Hearing Impaired Children, run by IRCCS Burlo Garofolo at 5 sites in 2 countries.
Trial summary
The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the… Read more about this study
- Who is it for?
- Ages 4 to 36 months
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Stimuli
- How many people
- 180 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 3 Jan 2021to 31 Dec 2024
- Phase
- Observational
- 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 4 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Participants with and without hearing impairment
Who may be able to join
- Normal or corrected-to-normal vision
- No history of relevant neurological or psychiatric concomitant disease
- Age: 4-36 months
- At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects)
Who cannot join
- Developmental disorders
- Unwillingness of the subject to participate further
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Italy4 sites, 1 recruiting
- Active, not recruiting
UOC Otorinolaringoiatria
Padova
- Active, not recruiting
Università degli Studi di Perugia
Perugia
- Active, not recruiting
Ospedale Martini
Torino
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Eva Orzan, MD, +39.040.3785.537, eva.orzan@burlo.trieste.it
Amanda Saksida
About this study
Official title: Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment
The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.
- Conditions
- Hearing Impaired Children
- Being tested
- Stimuli
- Keywords
- Pupillometry, Hearing threshold, Pediatric cochlear implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimuliOther
Auditory Stimuli: Pure tone bursts with main frequencies of 500, 1000, 2000, and 4000 Hz. Each tone will be presented at 10dB above the estimated individual threshold per frequency and compared to the responses to trials without auditory stimuli. Auditory stimulus duration: 25ms, there is 200ms baseline period before each trial, and 2000 ms interstimulus interval.
Visual stimuli: an animated movie adapted for the age and controlled for luminosity levels.
Pupil data will be collected through a "Tobii PRO" screen-based eye-tracker that measures eye-movements and pupil dilation using the infrared light cameras.
| Study group | Role | What they receive |
|---|---|---|
| Hearing threshold without aids | Case group with hearing impairment (HI) (hearing threshold >35 dB) without aids Receives: Other: Stimuli | |
| Hearing threshold with cochlear implant | Case group with hearing threshold corrected with cochlear implant (CI) Receives: Other: Stimuli | |
| Hearing threshold with aids | Case group with hearing threshold corrected with hearing aids Receives: Other: Stimuli | |
| Control group | Control group of normally hearing age-matched children Receives: Other: Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity index of pupillometry test
The peak and the average pupil dilation will be defined for each trial and the difference between trials below and above the threshold will be defined within each block. The difference between the trials with and without audible stimuli will be assessed using the multiple corrected t- tests. The sensitivity index of the pupillometric exam compared to the audiometry results will be computed for the whole group using a signal detection analysis.
Measured: Within 30 minutes from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start3 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired ChildrenStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317493
- Sponsor's protocol ID
- RC 15/2021
- Status last verified
- Jun 2024
- First submitted
- 12 Mar 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment
- ClinicalTrials.gov ID
- NCT06317493
- Acronym / sponsor ID
- RC 15/2021
- Conditions
- Hearing Impaired Children
- Keywords
- Pupillometry, Hearing threshold, Pediatric cochlear implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Mar 2024 (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 results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hearing threshold without aids | – | Other: StimuliCase group with hearing impairment (HI) (hearing threshold >35 dB) without aids |
| Hearing threshold with cochlear implant | – | Other: StimuliCase group with hearing threshold corrected with cochlear implant (CI) |
| Hearing threshold with aids | – | Other: StimuliCase group with hearing threshold corrected with hearing aids |
| Control group | – | Other: StimuliControl group of normally hearing age-matched children |
Who may qualify
- Ages
- 4 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants with and without hearing impairment
Key inclusion criteria (4 listed)
- Normal or corrected-to-normal vision
- No history of relevant neurological or psychiatric concomitant disease
- Age: 4-36 months
- At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects)
Key exclusion criteria (2 listed)
- Developmental disorders
- Unwillingness of the subject to participate further
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 |
|---|---|---|
| StimuliAuditory Stimuli: Pure tone bursts with main frequencies of 500, 1000, 2000, and 4000 Hz. Each tone will be presented at 10dB above the estimated individual threshold per frequency and compared to the responses to trials without auditory stimuli. Auditory stimulus duration: 25ms, there is 200ms baseline period before each trial, and 2000 ms interstimulus interval. Visual stimuli: an animated movie adapted for the age and controlled for luminosity levels. Pupil data will be collected through a "Tobii PRO" screen-based eye-tracker that measures eye-movements and pupil dilation using the infrared light cameras. | Other | Control group, Hearing threshold with aids, Hearing threshold with cochlear implant, Hearing threshold without aids |
Primary outcome
Sensitivity index of pupillometry test
Time frame: Within 30 minutes from enrolment
The peak and the average pupil dilation will be defined for each trial and the difference between trials below and above the threshold will be defined within each block. The difference between the trials with and without audible stimuli will be assessed using the multiple corrected t- tests. The sensitivity index of the pupillometric exam compared to the audiometry results will be computed for the whole group using a signal detection analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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. This study is not recruiting at the moment.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Impaired Children, run by IRCCS Burlo Garofolo at 5 sites in 2 countries.
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 13 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 5 sites in Italy, Slovenia. 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 Eva Orzan, MD (+39.040.3785.537, eva.orzan@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity index of pupillometry test (time frame: Within 30 minutes from enrolment). 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 13 Jun 2024.