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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06406088




Registration number
NCT06406088
Ethics application status
Date submitted
1/05/2024
Date registered
9/05/2024
Date last updated
9/05/2024

Titles & IDs
Public title
EarGenie MVP Performance Evaluation
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
Secondary ID [1] 0 0
105500
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Impaired Children 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.
Timepoint [1] 0 0
Up to 18 months
Primary outcome [2] 0 0
Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants
Timepoint [2] 0 0
Up to 18 months

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.
Minimum age
1 Month
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bionics Institute - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Bionics Institute of Australia
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06406088
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colette McKay, PhD
Address 0 0
Bionics Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Colette M McKay, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 408698202
Fax 0 0
Email 0 0
cmckay@bionicsinstitute.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06406088