Towards Implementation of Universal Newborn Hearing Screening in Kenya

NCT07879326 — Not applicable, Recruiting, 400 participants, University of Washington

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mHealth OAE: Towards Implementation of Universal Newborn Hearing Screening in Kenya - R33 Phase (mTUNE-R33)

Registry	NCT07879326, acronym mTUNE-R33
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, screening
Enrollment	400 (Estimated)
Sponsor	University of Washington (Other); collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions	Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Interventions	Hearing and ear health screening (Device)
Dates	start 2026-09-24 (estimated), primary completion 2028-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-10-16, last updated 2026-10-16
Locations	1 site in Kenya

-Summary

The goal of this observational study is to learn if smartphone hearing screening devices can help to understand the role of ear infections in hearing loss in infants with HIV exposure. The main questions it will answer are 1) What is the screening accuracy of smartphone hearing screening? 2) What is the incidence of ear infections and of abnormal hearing screening findings in infants with and without HIV exposure? Researchers will follow infants with and without HIV exposure for 6 months and will use smartphone and conventional hearing and ear health screening devices at the same time to see if the smartphone devices can help detect ear infections. Parent and infant participants will visit the clinic 3 times over 6 months. At these visits, infants will have hearing and ear health checked using smartphone and conventional devices.

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+Detailed description

This study will leverage smartphone hearing screening devices to understand the role of otitis media with effusions in hearing loss in infants with HIV exposure. Aim 1 will determine screening accuracy of smartphone-based otoacoustic emissions based hearing screening versus conventional otoacoustic emissions based hearing screening. Hypotheses. Sensitivity and specificity will be high for smartphone otoacoustic emissions testing vs conventional otoacoustic emissions testing. Smartphone otoacoustic emissions testing can detect hearing loss in high-risk infants. Aim 2 will estimate and compare incidence of otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions in infants with and without HIV exposure. Hypothesis. Incidence of otitis media with effusions will be high. Exploratory Hypothesis. HIV exposure will increase the risk of otitis media with effusions.

+Arms and interventions

Arm	Type	Interventions	Description
Hearing and ear health screening	Experimental	Device: Hearing and ear health screening	Hearing will be screened using smartphone and conventional devices that detect otoacoustic emissions. Ear health will be screened using a smartphone device that uses acoustic reflectometry to detect middle ear fluid.

Hearing and ear health screening (Device): Hearing will be screened using smartphone and conventional devices that detect otoacoustic emissions. Ear health will be screened using a smartphone device that uses acoustic reflectometry to detect middle ear fluid.

+Outcome measures

Primary outcomes

Otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions. [Enrollment, 3 and 6 months follow-up]: We will estimate prevalence at each time point and incidence of otitis media with effusions as events per 1000 child weeks.
Screening accuracy of smartphone-based otoacoustic emissions based hearing screening versus conventional otoacoustic emissions based hearing screening. [At enrollment, 3 and 6 months follow-up]: We will estimate sensitivity and specificity of smartphone OAE, using conventional OAE as a gold standard. We will calculate agreement between smartphone and conventional OAE using Spearman rank correlation coefficients and Kappa test statistics.

+Eligibility

Sex: All, ages: 5 Months to 7 Months, accepts healthy volunteers

Inclusion Criteria:

* Is at least 18 years old
* Is a biological mother for the infant participant
* Willing to disclose HIV status with confirmation from medical record
* Planning to reside in the study catchment for the next 6 months

Infants must meet all of the following criteria:

* Age 5 to 7 months
* at least one patent ear canal

Exclusion Criteria:

• Unwilling to provide locator information for contact

+Locations (1)

Facility	City	Country	Status
Mathare North Health Centre	Nairobi	Kenya	Recruiting

+Investigators

Sarah Benki-Nugent, PhD, Principal investigator, University of Washington

+Funding

NIH grants: R33DC021643