RECRUITING

Preschool Hearing Screening

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening

Quick Facts

Study Start:2023-10-01
Study Completion:2028-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06058767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age 2:0 - 6:0 years
  2. 2. Enrolled in a community-based preschool program
  1. 1. Known permanent HL, by parental or school report
  2. 2. Use of a hearing assistive device
  3. 3. Parent does not consent for hearing screening
  4. 4. Child was screened previously for this study
  5. 5. Child is not present in preschool on day of hearing screening

Contacts and Locations

Study Contact

Jihyun R Stephans, BS
CONTACT
415-530-0830
Jihyun.stephans@ucsf.edu

Principal Investigator

Dylan K Chan, MD, PhD
PRINCIPAL_INVESTIGATOR
The University of California - San Francisco

Study Locations (Sites)

The University of California, San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Dylan K Chan, MD, PhD, PRINCIPAL_INVESTIGATOR, The University of California - San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2028-02-01

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2028-02-01

Terms related to this study

Keywords Provided by Researchers

  • Hearing Loss
  • Preschool Hearing Screening
  • Otoacoustic Emissions
  • Pure-Tone Testing
  • Childhood Hearing Screening
  • Childhood Hearing Loss

Additional Relevant MeSH Terms

  • Hearing Loss
  • Hearing Disorders in Children
  • Hearing Loss, Sensorineural
  • Hearing Loss, Conductive
  • Hearing Loss, Unilateral
  • Hearing Loss, Noise-Induced
  • Hearing Loss, Mixed
  • Hearing Loss, Bilateral