- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675941
Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age (SI 360)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie-Noëlle CALMELS, Dr
- Phone Number: +33 5-61-77-95-77
- Email: calmels.mn@chu-toulouse.fr
Study Contact Backup
- Name: Aurore BERLAND
- Email: aurore.berland@asei.asso.fr
Study Locations
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-
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Ramonville-Saint-Agne, France, 31522
- ASEI, Unité Ressources Audition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Ongoing treatment that may affect alertness
- Unstable ADHD
- History of tympanic surgery for chronic otitis media
- Legal impossibility
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children aged 7
|
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. |
|
Children aged 8 to 9 years
|
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. |
|
Children aged 10 to 11 years
|
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. |
|
Children aged 12 to 13 years
|
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. |
|
Children aged 14 to 15 years
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
percentage of correct word identification
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
average of auditory data
Time Frame: 2 hours
|
2 hours
|
|
difference between a natural sound environment vs. a SpeechInNoise environment
Time Frame: 2 hours
|
2 hours
|
|
Difference between scores obtained with the 360 Immersion System and scores from the literature
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aurore BERLAND, ASEI
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- RC31/26/0048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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