Otitis Media with Effusion Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Kenya
Mathare North Health Centre
RECRUITING
Nairobi
Contact Information
Primary
Sarah Benki-Nugent, PhD
benki@u.washington.edu
206-685-9713
Time Frame
Start Date: 2026-09-24
Estimated Completion Date: 2028-09
Participants
Target number of participants: 400
Treatments
Experimental: 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.
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Leads: University of Washington

This content was sourced from clinicaltrials.gov