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NCT06058767 · ClinicalTrials.gov registry record · NA
Preschool Hearing Screening
A NA study of Hearing Loss and Hearing Loss, Sensorineural, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- NA
- Development phase
- 13,764
- Enrollment target
- 1
- Study location
NCT06058767 is a NA study of Hearing Loss and Hearing Loss, Sensorineural that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 13,764 participants, above the 5,884-participant average among 58 other Hearing Loss trials with a reported enrollment target (134% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06058767, a NA study of Hearing Loss and Hearing Loss, Sensorineural, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- NA
- Development phase
- 13,764 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Otoacoustic Emissions Testing
- OTHER Pure Tone Audiometry
Study Locations (1)
California
- The University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,764 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2028-02-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06058767
The ClinicalTrials.gov registry entry for NCT06058767 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 13,764 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 5,884-participant average among 58 other Hearing Loss trials with a reported enrollment target (134% higher). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which Otoacoustic Emissions Testing is the first listed.
NCT06058767 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06058767 about?
NCT06058767 is a clinical study titled "Preschool Hearing Screening". 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 uncerta...
What is the current status of trial NCT06058767?
This trial is currently recruiting. It is a NA study. The enrollment target is 13,764 participants. The study started on 2023-10-01. Estimated completion is 2028-02-01.
What conditions does trial NCT06058767 study?
This clinical trial studies the following conditions: Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral, Hearing Loss, Conductive.
What interventions are being tested in trial NCT06058767?
The interventions under investigation include: Otoacoustic Emissions Testing (OTHER), Pure Tone Audiometry (OTHER).
Who is sponsoring clinical trial NCT06058767?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06058767 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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