Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 28,000 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 6
Healthy Volunteers: f
View:

• Age 2:0 - 6:0 years

• Enrolled in a community-based preschool program

Locations
United States
California
The University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Jihyun R Stephans, BS
Jihyun.stephans@ucsf.edu
415-530-0830
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 28000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov

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