Hearing Loss, Bilateral or UnilateralmTUNE-R33NCT07879326
Towards Implementation of Universal Newborn Hearing Screening in Kenya
A study testing Hearing and ear health screening in people with Hearing Loss, Bilateral or Unilateral and Otitis Media With Effusion in Children, run by University of Washington at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
- What is being tested?
- Hearing and ear health screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteKenya
- Study dates
- 24 Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Unwilling to provide locator information for contact
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: mHealth OAE: Towards Implementation of Universal Newborn Hearing Screening in Kenya - R33 Phase (mTUNE-R33)
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.
Read the 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.
- Being tested
- Hearing and ear health screening
- Keywords
- Hearing Loss, Otitis Media with Effusion
- Medical subject headings
- Hearing Loss, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing and ear health screeningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hearing and ear health screening | Experimental | 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. Receives: Device: Hearing and ear health screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions.
We will estimate prevalence at each time point and incidence of otitis media with effusions as events per 1000 child weeks.
Measured: Enrollment, 3 and 6 months follow-up
Screening accuracy of smartphone-based otoacoustic emissions based hearing screening versus conventional otoacoustic emissions based hearing screening.
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.
Measured: At enrollment, 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start24 Sep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral or UnilateralStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Sarah Benki-Nugent, University of Washington
- Investigators
- Sarah Benki-Nugent, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879326
- Sponsor's protocol ID
- STUDY00025776
- Other IDs
- 4R33DC021643-03
- Acronym
- mTUNE-R33
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data other than patient direct or indirect identifiers will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth OAE: Towards Implementation of Universal Newborn Hearing Screening in Kenya - R33 Phase (mTUNE-R33)
- ClinicalTrials.gov ID
- NCT07879326
- Acronym / sponsor ID
- mTUNE-R33 / STUDY00025776
- Keywords
- Hearing Loss, Otitis Media with Effusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing and ear health screening | Experimental | Device: Hearing and ear health screeningHearing 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. |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- Age 5 to 7 months
Key exclusion criteria (1 listed)
- Unwilling to provide locator information for contact
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing and ear health screeningHearing 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. | Device | Hearing and ear health screening |
Primary outcome
Otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions.
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. All data other than patient direct or indirect identifiers will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Benki-Nugent, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing and ear health screening in people with Hearing Loss, Bilateral or Unilateral and Otitis Media With Effusion in Children, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Benki-Nugent, PhD (206-685-9713, benki@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions. (time frame: Enrollment, 3 and 6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.