Assessing Speech Perception and Amplification Benefit During Infancy

Hearing Loss Clinical Trial

Official title:

Assessing Speech Perception and Amplification Benefit During Infancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653999
• Other study ID #: 22-2169
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Amplification
• Hearing Loss
• Speech Perception

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)