Last reviewed · How we verify
NCT06058767
Preschool Hearing Screening
NA trial testing Otoacoustic Emissions Testing in Hearing Loss in 13,764 participants. Currently enrolling.
1 February 2028
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 13,764 |
| Start date | 1 October 2023 |
| Primary completion | 1 February 2028 |
| Estimated completion | 1 February 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Otoacoustic Emissions Testing
- Pure Tone Audiometry
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
- Hearing Disorders in Children — all drugs for Hearing Disorders in Children →
- Hearing Loss, Sensorineural — all drugs for Hearing Loss, Sensorineural →
- Hearing Loss, Conductive — all drugs for Hearing Loss, Conductive →
Sponsor
University of California, San Francisco
Who can join
Adults 2 to 6, any sex, with Hearing Loss or Hearing Disorders in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06058767
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hearing Loss
Currently open trials in the same condition.
- NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
- NCT07506408 — Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Gene · NA · recruiting
- NCT07218913 — Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III · Phase 1 · recruiting
- NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit · NA · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting
Other University of California, San Francisco trials
Trials by the same sponsor.
- NCT05284773 — Screening for Acute Malnutrition · NA · withdrawn
- NCT04634851 — Video Home Visits for Dietary Counselling · NA · not yet recruiting
- NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M · Phase 1, PHASE2 · not yet recruiting
- NCT07534098 — Intervention for Hearing Health Among Native Americans · NA · not yet recruiting
- NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT) · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06058767 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 2 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06058767.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing