Hearing Screening for Childhood Hearing Loss

N/A

Recruiting

Led By Dylan K Chan, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 2:0 - 6:0 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after screening

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to evaluate the effectiveness of screening for hearing loss in preschoolers to reduce the risk of speech and language delays.

Who is the study for?

This trial is for preschool children aged between 2 and 6 years who are enrolled in community-based preschool programs. It's not for kids whose parents don't consent, those already screened in this study, absent on screening day, using hearing aids, or known to have permanent hearing loss.

What is being tested?

The study tests two methods of detecting hearing loss: a two-stage process with Pure-tone audiometry and Otoacoustic emissions (TS-PO), versus a single-stage Otoacoustic emissions test (SS-O). The goal is to see if SS-O alone can match the effectiveness of TS-PO when used in preschools.

What are the potential side effects?

There are no direct side effects from participating as both Pure-tone audiometry and Otoacoustic emissions testing are non-invasive standard procedures used to screen hearing ability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2 and 6 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants identified with hearing loss

Secondary study objectives

Percentage of children with sensorineural hearing loss (SNHL)

Percentage of participants identified with hearing loss out of all referred

Percentage of participants referred for evaluation after screening

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Single-Stage OAE hearing screening (SS-O)Active Control2 Interventions

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.

Group II: Two-stage PTA+OAE hearing screening (TS-PO)Active Control2 Interventions

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.

0 / 1Eligibility criteria met