| NCT ID | NCT06058767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 13,764 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 13,764 participants in total. It began in 2023-10-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
Dylan K Chan, MD, PhD
PRINCIPAL INVESTIGATOR
The University of California - San Francisco
Frequently Asked Questions
Who can join the NCT06058767 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 6 Years, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06058767 currently recruiting?
Yes, NCT06058767 is actively recruiting participants. Contact the research team at Jihyun.stephans@ucsf.edu for enrollment information.
Where is the NCT06058767 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06058767 clinical trial?
NCT06058767 is sponsored by University of California, San Francisco. The principal investigator is Dylan K Chan, MD, PhD at The University of California - San Francisco. The trial plans to enroll 13,764 participants.