Assessing Speech Perception and Amplification Benefit During Infancy

Recruiting

• Conditions: Hearing Loss; Children With Hearing Differences; Amplification; Speech Perception
• Interventions: Device: Hearing Aids

• Registration Number: NCT05653999
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Study Start: 2023-03-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hearing Loss	Hearing Aids	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.

Primary Outcome Measures

Name	Time	Method
Behavioral Speech Perception	Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)	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.

Secondary Outcome Measures

Name	Time	Method
Aided Behavioral Speech Perception Improvement	Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)	Scores are measured from 0 to 2.03. Higher scores indicate greater benefit from hearing aid use in the hearing loss cohort.

Trial Locations

Locations (1)

University of Colorado School of Medicine - Speech Perception Over Time Lab; 🇺🇸 Aurora, Colorado, United States