Hearing screening for preschool children
Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening
NA · University of California, San Francisco · NCT06058767
This study is testing two different ways to check hearing in preschool children to see which method works better for finding hearing loss early and helping kids who might struggle with speech and language.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 13764 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06058767 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the effectiveness of two different hearing screening methods for preschool children: a two-stage approach combining Pure-tone audiometry (PTA) and otoacoustic emissions (OAE) versus a single-stage OAE screening. A diverse group of 28,000 preschool-age children will be recruited from community-based preschool centers, where each child will undergo both screening methods. The goal is to identify hearing loss early, which is crucial for preventing speech and language delays in children who are deaf or hard-of-hearing. The outcomes will be compared within subjects to assess which method is more effective in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 6 years enrolled in community-based preschool programs.
Not a fit: Children with known permanent hearing loss or those using hearing assistive devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of hearing loss in preschool children, facilitating timely intervention and support.
How similar studies have performed: Previous studies have shown the efficacy of OAE screening in preschool settings, suggesting that this approach may be effective, though the specific comparison being made in this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 2:0 - 6:0 years 2. Enrolled in a community-based preschool program Exclusion Criteria: 1. Known permanent HL, by parental or school report 2. Use of a hearing assistive device 3. Parent does not consent for hearing screening 4. Child was screened previously for this study 5. Child is not present in preschool on day of hearing screening
Where this trial is running
San Francisco, California
- The University of California, San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Dylan K Chan, MD, PhD — The University of California - San Francisco
- Study coordinator: Jihyun R Stephans, BS
- Email: Jihyun.stephans@ucsf.edu
- Phone: 415-530-0830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Hearing Disorders in Children, Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Unilateral, Hearing Loss, Noise-Induced, Hearing Loss, Mixed, Hearing Loss, Bilateral