Assessing Speech Perception and Amplification Benefit During Infancy
NCT ID: NCT05653999
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2023-03-10
2025-05-28
Brief Summary
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Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification (i.e., aided condition) compared to when tested without amplification (i.e., unaided condition). Infants fit with optimally programmed amplification will perform similarly to the infants with typical hearing on speech discrimination tasks.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal Hearing
Group 1 will consist of approximately 20 infants with normal hearing. This cohort will have passed their newborn hearing screenings and will pass audiologic measurements on the day of testing. Audiologic measurements include tympanometry to determine middle ear function and otoacoustic emissions testing to determine cochlear integrity.
No interventions assigned to this group
Hearing Loss
Group 2 will consist of approximately 20 infants with diagnosed bilateral sensorineural hearing loss ranging from mild to severe. These infants will also pass audiologic measures on the day of testing (tympanometry as described in group 1), currently use bilateral air-conduction hearing aids, and are enrolled in early intervention services.
Hearing Aids
Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.
Interventions
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Hearing Aids
Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.
Eligibility Criteria
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Inclusion Criteria
* English is the primary spoken language in the home
* Demonstrated ability to complete a conditioned head turn via visual reinforcement audiometry (VRA)
* If normal hearing
-Normal hearing sensitivity bilaterally
* If Hearing Loss
* Children with diagnosis of bilateral sensorineural hearing ranging from mild to severe
* Children currently using hearing aids
* Children currently enrolled in intervention
Exclusion Criteria
* Children with abnormal tympanometry on the day of testing
* Children with concerns of secondary disabilities
* Children with Auditory Neuropathy
* Concerns of hearing loss in normal hearing children
6 Months
36 Months
ALL
Yes
Sponsors
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Sonova AG
INDUSTRY
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Kristin M Uhler, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado School of Medicine
Locations
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University of Colorado School of Medicine - Speech Perception Over Time Lab
Aurora, Colorado, United States
Countries
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Other Identifiers
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22-2169
Identifier Type: -
Identifier Source: org_study_id
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