Noise ExposureSI 360NCT07675941
Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age
An observational study of Noise Exposure and Normal Hearing, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure, Normal Hearing, Child
- What is being tested?
- Système Immersion 360
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Jul 2027
- Phase
- Observational
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 7 to 15 with normal hearing
Who may be able to join
- Children with normal hearing (average hearing thresholds at 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz less than 20 dB)
- Be between 7 and 15 years old
- Be a native French speaker, without bilingualism
- Have typical development, as assessed by a school level corresponding to their age;
- No objection from at least one of the two legal guardians
- Legal guardian registered with social security
- Able to understand instructions and information provided
Who cannot join
- Inability of the child to respond to tests
- Abnormal hearing thresholds
- Speech disorder treated by speech therapist
- Inability to understand instructions / to respond to tests
- Neurological conditions
- Multiple disabilities
Show all 10Show fewer
- Ongoing treatment that may affect alertness
- Unstable ADHD
- History of tympanic surgery for chronic otitis media
- Legal impossibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurore BERLAND contact
About this study
In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. These assessment situations are not representative of the functional difficulties encountered by people with hearing loss or Auditory Processing Disorder in their daily lives. In real life, "soundscapes" are diverse. Hearing assessment and rehabilitation should include the child's everyday environments as well as their lifestyle habits.
The Immersion 360 System (Virtual reality system) was developed specifically to virtually reproduce complex everyday sound experiences with realistic noise types and sound presentation conditions, enabling the assessment of auditory perception under test conditions similar to those encountered in daily life. Some of the sound environments offered by this innovative system have been standardized for adults. No standards exist for children, and we have limited knowledge regarding the development of speech perception skills in noise during childhood and adolescence. It seems essential to measure the age-related development of speech perception in realistic sound environments in order to establish reference data for children and adolescents.
This work will, through functional assessments of the auditory system and linguistic tests (speech perception in noise), provide a better understanding of the functional development of the central auditory system for speech perception in noise. The results collected from normo-hearing individuals in the age groups of interest will provide a clinical baseline for comparison with patients of the same age.
Read the detailed description
This is a single-center, descriptive, cross-sectional, preliminary study to describe the age-related distribution of speech perception scores in noise. The study will be non-randomized and conducted on healthy, hearing minor volunteers. The inclusion period will be 12 months, with each participant spending 1.5 to 2 hours in the study.
- Conditions
- Noise Exposure, Normal Hearing, Child
- Being tested
- Système Immersion 360
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Système Immersion 360Other
The children will be placed at the center of the 360 Immersion System. The four sound environments (school cafeteria: loud and constant noise; playground: fluctuating noise; street: ambient sound without speech; multi-voice noise or SpeechInNoise) will be played one after the other, and two lists of 20 sentences will be presented to the child in each environment, without the possibility of repetition, at the actual signal-to-noise ratio. The child will have to repeat the sentences. The "cafeteria," "playground," and street recordings will be played again to the child, with a different signal-to-noise ratio, making it more difficult for the child to perceive speech.
The session lasts approximately 45 minutes, but to limit fatigue for our young participants, a 15-minute break will be offered.
Children can also request a break themselves if they become tired. A certificate will be awarded to each of our healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Children aged 7 | Not described Receives: Other: Système Immersion 360 | |
| Children aged 8 to 9 years | Not described Receives: Other: Système Immersion 360 | |
| Children aged 10 to 11 years | Not described Receives: Other: Système Immersion 360 | |
| Children aged 12 to 13 years | Not described Receives: Other: Système Immersion 360 | |
| Children aged 14 to 15 years | Not described Receives: Other: Système Immersion 360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of correct word identification
Measured: 2 hours
Secondary outcomes (3)
average of auditory data
Measured: 2 hours
difference between a natural sound environment vs. a SpeechInNoise environment
Measured: 2 hours
Difference between scores obtained with the 360 Immersion System and scores from the literature
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Association act care educate include
- Responsible party
- Sponsor
- Investigators
- Aurore BERLAND, Principal investigator, ASEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675941
- Sponsor's protocol ID
- RC31/26/0048
- Acronym
- SI 360
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age
- ClinicalTrials.gov ID
- NCT07675941
- Acronym / sponsor ID
- SI 360 / RC31/26/0048
- Conditions
- Noise Exposure, Normal Hearing, Child
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Association act care educate include
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jun 2026 (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.
In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. These assessment situations are not representative of the functional difficulties encountered by people with hearing loss or Auditory Processing Disorder in their daily lives. In real life, "soundscapes" are diverse. Hearing assessment and rehabilitation should include the child's everyday environments as well as their lifestyle habits.
The Immersion 360 System (Virtual reality system) was developed specifically to virtually reproduce complex everyday sound experiences with realistic noise types and sound presentation conditions, enabling the assessment of auditory perception under test conditions similar to those encountered in daily life. Some of the sound environments offered by this innovative system have been standardized for adults. No standards exist for children, and we have limited knowledge regarding the development of speech perception skills in noise during childhood and adolescence. It seems essential to measure the age-related development of speech perception in realistic sound environments in order to establish reference data for children and adolescents.
This work will, through functional assessments of the auditory system and linguistic tests (speech perception in noise), provide a better understanding of the functional development of the central auditory system for speech perception in noise. The results collected from normo-hearing individuals in the age groups of interest will provide a clinical baseline for comparison with patients of the same age.
Detailed description
This is a single-center, descriptive, cross-sectional, preliminary study to describe the age-related distribution of speech perception scores in noise. The study will be non-randomized and conducted on healthy, hearing minor volunteers. The inclusion period will be 12 months, with each participant spending 1.5 to 2 hours in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Children aged 7 | – | Other: Système Immersion 360 |
| Children aged 8 to 9 years | – | Other: Système Immersion 360 |
| Children aged 10 to 11 years | – | Other: Système Immersion 360 |
| Children aged 12 to 13 years | – | Other: Système Immersion 360 |
| Children aged 14 to 15 years | – | Other: Système Immersion 360 |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 7 to 15 with normal hearing
Key inclusion criteria (7 listed)
- Children with normal hearing (average hearing thresholds at 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz less than 20 dB)
- Be between 7 and 15 years old
- Be a native French speaker, without bilingualism
- Have typical development, as assessed by a school level corresponding to their age;
- No objection from at least one of the two legal guardians
Key exclusion criteria (10 listed)
- Inability of the child to respond to tests
- Abnormal hearing thresholds
- Speech disorder treated by speech therapist
- Inability to understand instructions / to respond to tests
- Neurological conditions
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 |
|---|---|---|
| Système Immersion 360The children will be placed at the center of the 360 Immersion System. The four sound environments (school cafeteria: loud and constant noise; playground: fluctuating noise; street: ambient sound without speech; multi-voice noise or SpeechInNoise) will be played one after the other, and two lists of 20 sentences will be presented to the child in each environment, without the possibility of repetition, at the actual signal-to-noise ratio. The child will have to repeat the sentences. The "cafeteria," "playground," and street recordings will be played again to the child, with a different signal-to-noise ratio, making it more difficult for the child to perceive speech. The session lasts approximately 45 minutes, but to limit fatigue for our young participants, a 15-minute break will be offered. Children can also request a break themselves if they become tired. A certificate will be awarded to each of our healthy volunteers. | Other | Children aged 10 to 11 years, Children aged 12 to 13 years, Children aged 14 to 15 years, Children aged 7, Children aged 8 to 9 years |
Primary outcome
percentage of correct word identification
Time frame: 2 hours
3 secondary outcomes
average of auditory data
Time frame: 2 hours
difference between a natural sound environment vs. a SpeechInNoise environment
Time frame: 2 hours
Difference between scores obtained with the 360 Immersion System and scores from the literature
Time frame: 2 hours
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 30 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Aurore BERLAND contact
Aurore BERLAND principal investigator
ASEI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Exposure and Normal Hearing, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Jun 2026. 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 France. 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?
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 Marie-Noëlle CALMELS, Dr (+33 5-61-77-95-77, calmels.mn@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of correct word identification (time frame: 2 hours). 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 30 Jun 2026.