Preschool Hearing Screening

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06058767
Status
Recruiting
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Conditions

  • Hearing Disorders in Children
  • Hearing Loss
  • Hearing Loss, Bilateral
  • Hearing Loss, Conductive
  • Hearing Loss, Mixed
  • Hearing Loss, Noise-Induced
  • Hearing Loss, Sensorineural
  • Hearing Loss, Unilateral

Eligibility Criteria

Sex
ALL
Age
2 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Otoacoustic Emissions Testing — OTHER
    An OAE (Otoacoustic Emissions) test is a non-invasive, quick, and commonly used hearing screening method. It is a non-behavioral test to access the function of the cochlea, which is the inner ear's sensory organ responsible for detecting sound.
  • Pure Tone Audiometry — OTHER
    The PTA testing is a hearing screening method used to assess an individual's ability to hear pure tones at different frequencies and at different sound levels. It is a behavioral test in which a child is conditioned to perform a play-based task upon hearing sounds at multiple frequencies.

Study Details

Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D/HH children, reducing the likelihood of speech and language delays. A diverse group of 13,764 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results. In addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D/HH children.

Key Dates

Start date
Oct 1, 2023
Status verified
Jan 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
13,764 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Two-stage PTA+OAE hearing screening (TS-PO)
    Children initially undergo a PTA screening test, recommended by the American Academy of Audiology and supported by published evidence. This screening assesses their hearing ability through conditioned-play responses to 25 dB HL pure tones at 1000, 2000, and 4000 Hz, yielding results of PASS, REFER, or UNABLE to test. Those UNABLE to be tested will receive a second OAE screening. Children who REFER either the PTA or OAE test, or are UNABLE to be tested by both, are referred to their pediatrician for further evaluation and management. All children will undergo both PTA and OAE screening and the group allocation will be determined post hoc.
  • Active Comparator: Single-Stage OAE hearing screening (SS-O)
    Children undergo only screening with OAEs, detecting distortion-product OAEs in response to tone pairs centered at 2000, 3000, 4000, and 5000 Hz. If they PASSED the OAE, they would be assigned a PASS for the SS-O Hearing Screen outcome; if they REFERRED or were UNABLE to test, they would be assigned a REFER. All children will undergo both PTA and OAE screening and the group allocation will be determined post hoc.

Primary Outcome Measure

Percentage of participants identified with hearing loss [ Time Frame: 6 months after screening ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of California, San FranciscoSan FranciscoCalifornia94158
Jihyun R Stephans, BS
[email protected]
415-530-0830
David K Perez, BA
[email protected]
628-233-9937‬
Dylan K Chan, MD, PhD (PRINCIPAL_INVESTIGATOR)

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