Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406088
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-01
Brief Title:
EarGenie MVP Performance Evaluation
Sponsor:
The Bionics Institute of Australia
Organization:
The Bionics Institute of Australia
Study Overview
Official Title:
EarGenie Minimum Viable Product MVP Performance Evaluation Sensitivity and Specificity of a Test of Sound Detection and Discrimination Using Functional Near-infrared Spectroscopy fNIRS in a Single Group Trial of Normal Hearing Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product MVP in normal hearing infants The EarGenie MVP tests for detection and discrimination of sounds will be administered and the sensitivity and specificity of the tests will be estimated for a range of sound levels detection and speech sound contrasts discrimination
Detailed Description:
Procedures
All procedures will be carried out in a single test session
Determination of infant eligibility will be undertaken by confirming that the infant has passed hearing screening or diagnostic audiological assessment and is under the age of 2 years
Before completing the fNIRS tests the infant will undergo otoscopy and tympanometry to exclude possible temporary conductive hearing loss associated with abnormal tympanometric results These are standard audiological procedures If the infant has abnormal tympanometric results in both ears on the day the test session will be rescheduled The parentguardian will be advised of the finding and its possible consequences possible conductive hearing loss possible progression to acute otitis media and advised to seek medical advice should the infant show signs of illness or if hearing loss is suspected
All assessments in the fNIRS test session will be undertaken by qualified paediatric audiologists who are trained in the fNIRS procedures
For the fNIRS tests the infant will be asleep or in a quietly entertained response state
After the headgear is placed on the infants head an optode calibration procedure is undertaken to ensure the equipment is ready During the actual test blocks of speech sounds lasting 54 seconds will be played to the infant either via tubephone or via speakers During and after the test session the infant will be monitored for any signs of discomfort or distress Testing will discontinue if the infant is not either asleep or in a quiet response state
For the detection test a single speech sound BA will be presented at several levels 35 50 and 65 dBSPL and the test blocks will include no sound blocks to allow estimates of false positive results
For the discrimination test three different speech contrasts will be presented BATEA BABEE and BAGA at 65 dB SPL The test will also include blocks of BABA to allow estimates of false positive rates
For each infant the sound levels at which BA evoked a statistically significant response will be recorded andor the speech contrasts which evoked a significant discrimination response will be recorded Each infant will either have a detection test or a discrimination test or both if their response state allows At least 50 full detection and 50 full discrimination test results for estimating sensitivity and specificity outcome measures will be obtained
All procedures will be carried out in a single test session
Determination of infant eligibility will be undertaken by confirming that the infant has passed hearing screening or diagnostic audiological assessment and is under the age of 2 years
Before completing the fNIRS tests the infant will undergo otoscopy and tympanometry to exclude possible temporary conductive hearing loss associated with abnormal tympanometric results These are standard audiological procedures If the infant has abnormal tympanometric results in both ears on the day the test session will be rescheduled The parentguardian will be advised of the finding and its possible consequences possible conductive hearing loss possible progression to acute otitis media and advised to seek medical advice should the infant show signs of illness or if hearing loss is suspected
All assessments in the fNIRS test session will be undertaken by qualified paediatric audiologists who are trained in the fNIRS procedures
For the fNIRS tests the infant will be asleep or in a quietly entertained response state
After the headgear is placed on the infants head an optode calibration procedure is undertaken to ensure the equipment is ready During the actual test blocks of speech sounds lasting 54 seconds will be played to the infant either via tubephone or via speakers During and after the test session the infant will be monitored for any signs of discomfort or distress Testing will discontinue if the infant is not either asleep or in a quiet response state
For the detection test a single speech sound BA will be presented at several levels 35 50 and 65 dBSPL and the test blocks will include no sound blocks to allow estimates of false positive results
For the discrimination test three different speech contrasts will be presented BATEA BABEE and BAGA at 65 dB SPL The test will also include blocks of BABA to allow estimates of false positive rates
For each infant the sound levels at which BA evoked a statistically significant response will be recorded andor the speech contrasts which evoked a significant discrimination response will be recorded Each infant will either have a detection test or a discrimination test or both if their response state allows At least 50 full detection and 50 full discrimination test results for estimating sensitivity and specificity outcome measures will be obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None