Trial Outcomes & Findings for EarGenie: Assessment of a Minimum Viable Product (NCT NCT05962814)

Results Overview

Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. "A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants." PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm). For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for "Ba" versus "Ga".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.

Results posted on

2025-02-06

Participant Flow

11 Participants were recruited via word of mouth between August 2023 and February 2024.

One infant was found to have middle ear disfunction on the tympanometry test, and so was excluded from the study and did not complete an fNIRS test

Participant milestones

Participant milestones
Measure	fNIRS Infants who have a test completed with EarGenie MVP in a single test session EarGenie MVP test: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests 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. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	fNIRS Infants who have a test completed with EarGenie MVP in a single test session EarGenie MVP test: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests 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. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
Overall Study failed eligibility	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	fNIRS n=10 Participants Infants who have a test completed with EarGenie MVP in a single test session EarGenie MVP test: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests 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. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
Age, Customized 1-24 months	10 Participants n=10 Participants
Sex: Female, Male Female	6 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=10 Participants
Region of Enrollment Australia	10 participants n=10 Participants

PRIMARY outcome

Timeframe: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.

Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. "A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants." PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm). For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for "Ba" versus "Ga".

Outcome measures

Outcome measures
Measure	fNIRS n=10 Participants Infants who have a test completed with EarGenie MVP in a single test session EarGenie MVP test: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests 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. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
Prevalence of Significant fNIRS Detection and Discrimination Responses significant detection response to BA at 65 dB SPL · with	4 Participants
Prevalence of Significant fNIRS Detection and Discrimination Responses significant detection response to BA at 65 dB SPL · without	6 Participants
Prevalence of Significant fNIRS Detection and Discrimination Responses significant discrimination response to BA/GA contrast · with	1 Participants
Prevalence of Significant fNIRS Detection and Discrimination Responses significant discrimination response to BA/GA contrast · without	9 Participants
Prevalence of Significant fNIRS Detection and Discrimination Responses Response morphologies consitent with morphologies of research device · with	10 Participants
Prevalence of Significant fNIRS Detection and Discrimination Responses Response morphologies consitent with morphologies of research device · without	0 Participants

SECONDARY outcome

Timeframe: Adverse effects are noted during, and for 24 hours following the single test session of the infant. Incidence of events is calculated after the last infant is tested.

Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test. If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved.

Outcome measures

Outcome measures
Measure	fNIRS n=10 Participants Infants who have a test completed with EarGenie MVP in a single test session EarGenie MVP test: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests 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. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse events · with	0 Participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse events · without	10 Participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] no impression marks on skin, or impression marks that resolved within 3 hours · with	10 Participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] no impression marks on skin, or impression marks that resolved within 3 hours · without	0 Participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] signs of distress during test such as crying · with	0 Participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] signs of distress during test such as crying · without	10 Participants

Adverse Events

fNIRS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Colette McKay

Bionics Institute

Phone: +61 408698202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place