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Preschool Hearing Screening

Primary Purpose

Hearing Loss, Hearing Disorders in Children, Hearing Loss, Sensorineural

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Otoacoustic Emissions Testing
Pure Tone Audiometry
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hearing Loss focused on measuring Hearing Loss, Preschool Hearing Screening, Otoacoustic Emissions, Pure-Tone Testing, Childhood Hearing Screening, Childhood Hearing Loss

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 2:0 - 6:0 years Enrolled in a community-based preschool program Exclusion Criteria: Known permanent HL, by parental or school report Use of a hearing assistive device Parent does not consent for hearing screening Child was screened previously for this study Child is not present in preschool on day of hearing screening

Sites / Locations

  • The University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Two-stage PTA+OAE hearing screening (TS-PO)

Single-Stage OAE hearing screening (SS-O)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of participants identified with hearing loss
Percentage of children identified with hearing loss; (number of children identified with hearing loss) / (number of all screened children)

Secondary Outcome Measures

Percentage of participants successfully screened
Percentage of all children screened who were successfully screened, which compares the ability of each screening method to adequately screen a diverse population of 2-5-year-old children in a community-based preschool setting; (number of all screened - number of those UNABLE) / (number of all screened)
Percentage of participants referred for evaluation after screening
Percentage of children referred after hearing screening; (number of those referred)/(number of all screened)
Percentage of participants identified with hearing loss out of all referred
Percentage of children referred that were found to have HL, which reflect the burden on preschools, screening programs, and clinical providers (PCPs and audiologists) due to referrals and false positives; (number of children identified with hearing loss)/(number of all referred)
Percentage of children with sensorineural hearing loss (SNHL)
(number of children identified with SNHL)/(number of all screened)
Percentage of participants with conductive hearing loss (CHL)
(number of children identified with CHL)/(number of all screened)
Percentage of participants who underwent Intervention for HL
Percentage of children who underwent interventions such as cerumen management, medical and surgical management of otitis media, and hearing-aid fitting; (number of those that underwent intervention)/(number of all screened)

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06058767
Brief Title
Preschool Hearing Screening
Official Title
Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2028 (Anticipated)
Study Completion Date
February 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 28,000 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.
Detailed Description
1.1 Study Groups Each subject will undergo both PTA and OAE screening and be assigned post hoc to both TS-PO and SS-O groups with within-subject comparison of hearing screening outcomes. 1.2 Study Interventions In this study, we will compare the effectiveness of 1) TS-PO versus 2) SS-O in a community- based preschool setting to identify hearing loss. The interventions will be implemented in two distinct phases - a data collection phase, in which every subject will undergo both PTA and OAE screening; and group allocation phase, in which every subject will be allocated to both study groups (TS-PO and SS-O) virtually, for within-subject comparison. 1.2.1 Two-stage PTA+OAE Screening (TS-PO) Children will first undergo PTA screening, recommended for children aged 3 and older, using conditioned-play responses to 25 decibel (dB) HL pure tones at 1000, 2000, and 4000 Hz. Screening results include PASS, REFER, or UNABLE to test. Children unable to be tested immediately undergo OAE screening. Children who REFER either the PTA or the OAE test, or are UNABLE to be tested by both, are referred for further evaluation with their pediatrician. This two-stage method successfully screened 99.6% of preschoolers, with 3.1% identified with HL. 1.2.2 Single-Stage OAE Screening (SS-O) Children undergo screening with OAEs, detecting distortion-product OAEs in response to tone pairs centered at 2000, 3000, 4000, and 5000 Hz. Multiple studies support the efficacy of OAE hearing screening in preschool-aged children, with a success rate of 94% and identification of HL in 2.4%. 1.3 Study Timing and Duration Screening, recruitment, and enrollment will occur annually at each preschool site. Hearing screening will take place annually. Diagnostic testing will be completed within 6 months of hearing screening. 1.4 Attrition and Study Withdrawal Subjects are enrolled at the moment of screening, and all possible outcomes (including failure or inability to complete screening and loss to follow-up) will be included in the final analysis, eliminating the opportunity for voluntary withdrawal or attrition. 1.5 Site Recruitment and Subject Enrollment Preschool site participation models vary based on whether site or study personnel perform hearing screening and case management. Three participation models are outlined based on who conducts screening and diagnosis. Subject enrollment is performed by Site Personnel. A Screening and Enrollment Log (SEL) is maintained locally, with no identifiable information transmitted to the Study Team. Parents are notified of the hearing screening and study, with written or verbal permission obtained for screening. Children outside the inclusion age range (2.0-6.0 years) or with known permanent HL are not eligible. Children screened in previous years undergo annual screening, with only their first hearing screen used for analysis. 1.6 Study Procedures and Data Collection Screening Pathway Protocol covers site preparation, hearing screening, and screening outcomes. Screening Pathway Protocol involves screening personnel and training, including initial training and monitoring and quality assurance. Training levels of hearing screening personnel are defined as Level 1, Level 2, and Level 3 based on their screening experience. Data Collection involves collecting information on screening outcomes, equipment calibration, OAE and PTA screening protocols, PASS/REFER/UNABLE criteria, and randomization of test order. Randomization ensures unbiased test order presentation and is not related to group allocation. 1.7 Group Allocation Group allocation occurs after Data Collection. Subjects are assigned to either the TS-PO or SS-O group based on primary data, including PTA and OAE results, hearing screen outcomes (PASS or REFER), and final hearing outcomes (HL or No HL). Allocation involves assigning PASS outcomes based on PTA and OAE results, while REFER outcomes lead to determining the actual final hearing outcome (HL or No HL). This process generates comprehensive datasets for both comparator groups for subsequent data analysis of primary and secondary outcome variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Hearing Loss, Preschool Hearing Screening, Otoacoustic Emissions, Pure-Tone Testing, Childhood Hearing Screening, Childhood Hearing Loss

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each subject will undergo both PTA and OAE screening and be assigned post hoc to both TS-PO and SS-O groups with within-subject comparison of hearing screening outcomes.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-stage PTA+OAE hearing screening (TS-PO)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Single-Stage OAE hearing screening (SS-O)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Otoacoustic Emissions Testing
Intervention Description
An OAE (Otoacoustic Emissions) test is a non-invasive, quick, and commonly used hearing screening method. It is a non-behavioral test to access the function of the cochlea, which is the inner ear's sensory organ responsible for detecting sound.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pure Tone Audiometry
Intervention Description
The PTA testing is a hearing screening method used to assess an individual's ability to hear pure tones at different frequencies and at different sound levels. It is a behavioral test in which a child is conditioned to perform a play-based task upon hearing sounds at multiple frequencies.
Primary Outcome Measure Information:
Title
Percentage of participants identified with hearing loss
Description
Percentage of children identified with hearing loss; (number of children identified with hearing loss) / (number of all screened children)
Time Frame
6 months after screening
Secondary Outcome Measure Information:
Title
Percentage of participants successfully screened
Description
Percentage of all children screened who were successfully screened, which compares the ability of each screening method to adequately screen a diverse population of 2-5-year-old children in a community-based preschool setting; (number of all screened - number of those UNABLE) / (number of all screened)
Time Frame
At screening
Title
Percentage of participants referred for evaluation after screening
Description
Percentage of children referred after hearing screening; (number of those referred)/(number of all screened)
Time Frame
At screening
Title
Percentage of participants identified with hearing loss out of all referred
Description
Percentage of children referred that were found to have HL, which reflect the burden on preschools, screening programs, and clinical providers (PCPs and audiologists) due to referrals and false positives; (number of children identified with hearing loss)/(number of all referred)
Time Frame
6 months after screening
Title
Percentage of children with sensorineural hearing loss (SNHL)
Description
(number of children identified with SNHL)/(number of all screened)
Time Frame
6 months after screening
Title
Percentage of participants with conductive hearing loss (CHL)
Description
(number of children identified with CHL)/(number of all screened)
Time Frame
6 months after screening
Title
Percentage of participants who underwent Intervention for HL
Description
Percentage of children who underwent interventions such as cerumen management, medical and surgical management of otitis media, and hearing-aid fitting; (number of those that underwent intervention)/(number of all screened)
Time Frame
6 months after screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 2:0 - 6:0 years Enrolled in a community-based preschool program Exclusion Criteria: Known permanent HL, by parental or school report Use of a hearing assistive device Parent does not consent for hearing screening Child was screened previously for this study Child is not present in preschool on day of hearing screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihyun R Stephans, BS
Phone
415-530-0830
Email
Jihyun.stephans@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dylan K Chan, MD, PhD
Organizational Affiliation
The University of California - San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihyun R Stephans, BS
Phone
415-530-0830
Email
jihyun.stephans@ucsf.edu
First Name & Middle Initial & Last Name & Degree
David K Perez, BA
Phone
628-233-9937‬
Email
David.perez2@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Dylan K Chan, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25760393
Citation
Prieve BA, Schooling T, Venediktov R, Franceschini N. An Evidence-Based Systematic Review on the Diagnostic Accuracy of Hearing Screening Instruments for Preschool- and School-Age Children. Am J Audiol. 2015 Jun;24(2):250-67. doi: 10.1044/2015_AJA-14-0065.
Results Reference
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PubMed Identifier
30532159
Citation
Cedars E, Kriss H, Lazar AA, Chan C, Chan DK. Use of otoacoustic emissions to improve outcomes and reduce disparities in a community preschool hearing screening program. PLoS One. 2018 Dec 10;13(12):e0208050. doi: 10.1371/journal.pone.0208050. eCollection 2018.
Results Reference
background
PubMed Identifier
35175312
Citation
Brodie KD, David AP, Kriss H, Chan DK. Outcomes of an Early Childhood Hearing Screening Program in a Low-Income Setting. JAMA Otolaryngol Head Neck Surg. 2022 Apr 1;148(4):326-332. doi: 10.1001/jamaoto.2021.4430. Erratum In: JAMA Otolaryngol Head Neck Surg. 2022 Nov 1;148(11):1081-1082.
Results Reference
background
PubMed Identifier
23733793
Citation
Foust T, Eiserman W, Shisler L, Geroso A. Using otoacoustic emissions to screen young children for hearing loss in primary care settings. Pediatrics. 2013 Jul;132(1):118-23. doi: 10.1542/peds.2012-3868. Epub 2013 Jun 3.
Results Reference
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Preschool Hearing Screening

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