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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653999
Other study ID # 22-2169
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2023
Est. completion date April 1, 2024

Study information

Verified date January 2024
Source University of Colorado, Denver
Contact Kerry A Walker, AuD
Phone 3037243022
Email kerry.walker@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 36 Months
Eligibility Inclusion Criteria: - Children between the ages of 6 months and 36 months (inclusive) at the time of enrollment. - 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 born earlier than 35 weeks gestation - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hearing Aids
Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.

Locations

Country Name City State
United States University of Colorado School of Medicine - Speech Perception Over Time Lab Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Sonova AG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral Speech Perception To measure speech perception ability, infants are trained to complete a task in response to a change in a speech sound played over a speaker. Scores are given in d' (or equivalent) and are calculated from both true and false responses. Scores can range from 0.97 and 3.00. Scores above 1.28 are considered significantly above chance indicating successful perception of speech contrasts. To separate issues such as speech discrimination abilities versus proper conditioning, if a child is unable to discriminate a speech contrast (e.g., /ba-da/ or /sa-sha/) testing will transition to the 'easier' speech contrast /a-i/. If the child can discriminate between /a-i/, the investigators will repeat the previously tested contrast. Upon completion of this contrast the next contrast in will be assessed based on randomization ordering. If either contrast was not assessed/the child did not reach criterion, the participant will be rescheduled within 1 month, pending subject factors. Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
Secondary Aided Behavioral Speech Perception Improvement Scores are measured from 0 to 2.03. Higher scores indicate greater benefit from hearing aid use in the hearing loss cohort. Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
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