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Assessing Speech Perception and Amplification Benefit During Infancy

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653999
Collaborator
Sonova AG (Industry)
50
Enrollment
1
Location
5.9
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing Aids

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing Speech Perception and Amplification Benefit During Infancy
Anticipated Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
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.

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

Outcome Measures

Primary Outcome Measures

  1. Behavioral Speech Perception [Through study completion, up to 6 weeks.]

    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. Calculated 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 (e.g., either /ba-da/ or /sa-sha/). 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.

Secondary Outcome Measures

  1. Aided Behavioral Speech Perception Improvement [Through study completion, up to 6 weeks.]

    Scores are measured from 0 to 2.03. Higher scores indicate greater benefit from hearing aid use in the hearing loss cohort.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 36 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado School of Medicine - Speech Perception Over Time Lab Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • Sonova AG

Investigators

  • Principal Investigator: Kristin M Uhler, PhD, University of Colorado School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05653999
Other Study ID Numbers:
  • 22-2169
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Hearing Loss

Study Results

No Results Posted as of Dec 16, 2022