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Procedure

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants identified with hearing loss

Secondary outcome measures

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

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

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,210,575 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,969,458 Total Patients Enrolled

Dylan K Chan, MD, PhDPrincipal InvestigatorThe University of California - San Francisco

1 Previous Clinical Trials

210 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for participation in this research above or below 20 years?

"The age range that is eligible to enter this trial has been stipulated as between 2 and 6 years old."

Answered by AI

Do I meet the requisites to participate in this medical study?

"To qualify for enrollment, individuals must have a hearing impairment and be aged between 2 to 6 years old. Ultimately, 28000 patients are needed for the study's completion."

Answered by AI

Is there an active enrollment period for this experiment?

"The clinicaltrial.gov listing for this medical trial confirms that enrollment has concluded, with the original posting date on October 1st 2023 and last edit on September 21st of the same year. Despite its closure to further patients, there are a considerable 189 other available trials now open for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preschool Hearing Screening

2023. "Preschool Hearing Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058767.

All > Sensorineural Hearing Loss > Hearing Loss