Hearing Aids and the Brain

Hearing Loss Clinical Trial

Official title:

Hearing Aids and the Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279510
• Other study ID #: C2396-P
• Status: Completed
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hearing aids are being fit on inexperienced hearing aid users and the short-term and long-term effects are measured. This research aims to improve understanding of the individual factors that contribute to receiving benefit from hearing aids and lead to more individualized treatment of hearing loss.

Description:

Hearing aids are used to improve audibility for patients with hearing loss and improve speech perception. In addition to these immediate benefits, amplification has the potential to have long-term effects on higher level auditory processing abilities, such as cognition or other abilities required for complex listening tasks. These long-term acclimatization effects are not well understood and merit further behavioral and physiological examination. Hearing aids will be fit on inexperienced hearing aid users and outcome measures will be used to determine immediate and long-term effects of hearing aids. This research may provide a more detailed view of individual differences that contribute to receiving benefit from a hearing aid and may lead to more individualized treatment of hearing loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 50 years of age or older
• Bilateral, mild to moderately severe hearing loss
• Inexperienced hearing aid users

Exclusion Criteria:

• Subject deciding that they do not wish to wear hearing aids as necessitated per study protocol
• Audiometric thresholds that suggest research stimuli would not be audible
• Conductive hearing loss and/or other significant ear or hearing problems
• Non-native English speakers
• Conditions or circumstances that would preclude a participant from wearing hearing aids consistently or finishing the study
• An inability to perform or complete the experimental tasks

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• hearing aids
Subjects are fit with hearing aids.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evoked potential latency	Latency will be measured in milliseconds	Approximately 1 year
Primary	Evoked potential amplitude	Amplitude will be measured in microvolts	Approximately 1 year
Primary	Frequency following response magnitude	Magnitude of response measured in nanovolts	Approximately 1 year
Primary	Frequency following response timing	Timing measured by cross-correlation between stimulus and response	Approximately 1 year
Primary	Ongoing electroencephalography power	EEG power as a function of frequency recorded during words-in-noise measure	Approximately 1 year
Primary	Montreal Cognitive Assessment score	Assessment score from 1 to 30	Approximately 1 year
Primary	Reading Span	Percent correct recall on working memory task	Approximately 1 year
Primary	Hearing aid usage	Data logging from the hearing aid will provide usage in hours per day	Approximately 1 year
Primary	Word-in-noise perception testing	Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test	Approximately 1 year
Primary	Listening invested/required effort	Participants' rating of the effort required (0-9) and invested (0-9) for listening task	Approximately 1 year
Primary	Working memory testing	Performance on auditory working memory task	Approximately 1 year
Primary	Glasgow Hearing Aid Benefit Profile (GHABP)	Participants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations	Approximately 1 year