Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058767
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-09-21
Brief Title:
Preschool Hearing Screening
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children who are deaf or hard-of-hearing DHH 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 DHH children reducing the likelihood of speech and language delays
A diverse group of 28000 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 DHH children
A diverse group of 28000 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 DHH children
Detailed Description:
11 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
12 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
121 Two-stage PTAOAE 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 996 of preschoolers with 31 identified with HL
122 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 24
13 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
14 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
15 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 20-60 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
16 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 PASSREFERUNABLE criteria and randomization of test order Randomization ensures unbiased test order presentation and is not related to group allocation
17 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
12 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
121 Two-stage PTAOAE 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 996 of preschoolers with 31 identified with HL
122 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 24
13 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
14 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
15 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 20-60 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
16 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 PASSREFERUNABLE criteria and randomization of test order Randomization ensures unbiased test order presentation and is not related to group allocation
17 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None