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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06406088
Registration number
NCT06406088
Ethics application status
Date submitted
1/05/2024
Date registered
9/05/2024
Titles & IDs
Public title
EarGenie MVP Performance Evaluation
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Scientific 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
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Secondary ID [1]
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105500
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Impaired Children
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - EarGenie MVP test
Experimental: EarGenie MVP - Infants who have a test completed with EarGenie MVP in a single test session
Treatment: Devices: EarGenie MVP test
The EarGenie MVP test consists of placing the EarGenie headgear containing light emitting diodes (LEDs) and light detectors on the infant and running the fNIRS tests of sound detection or sound discrimination via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation in temporal and prefrontal regions of the cortex. Automatic analyses are run to determine whether the infant heard the sounds (at levels 35, 50, and 65 dBSPL) or discriminated between two sounds (Ba/Tea, Ba/Bee, or Ba/Ga). The infant will be in a natural sleep or quiet awake state when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.
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Assessment method [1]
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The primary outcome 1 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the detection test for three audible sound levels (65, 50, 35 dBSPL) within the comfortable loudness range.
Sensitivity for the detection test will be estimated as the proportion of infants for whom the test result showed a positive detection and specificity will be estimated as \[1- the proportion of infants whose test result for a control condition (silence) showed a (false) detection\].
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Timepoint [1]
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Up to 18 months
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Primary outcome [2]
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Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants
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Assessment method [2]
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The primary outcome 2 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the discrimination test for three difference speech sound contrasts differing in difficulty (BA/TEA, BA/BEE, and BA/GA), all presented at 65 dB SPL.
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Timepoint [2]
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Up to 18 months
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Eligibility
Key inclusion criteria
Each infant must meet all of the following criteria to be enrolled in this trial:
* Is between the ages of 1 and 24 months at the time of fNIRS testing.
* Has no known hearing loss, having either passed newborn hearing screening or diagnostic audiological assessment.
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
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Minimum age
1
Month
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Maximum age
24
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Infants with skin conditions such as cradle cap, eczema, or other skin conditions on the head will be excluded.
There are no additional exclusion criteria other than not meeting the inclusion criteria.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
15/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/12/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Bionics Institute - East Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Bionics Institute of Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06406088
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Colette McKay, PhD
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Address
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Bionics Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Colette M McKay, PhD
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Address
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Country
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Phone
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+61 408698202
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06406088