Clinical trial NCT03279510: Hearing Aids and the Brain
Official title: Hearing Aids and the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: auditory perception
hearing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evoked potential latency
timeFrame: Approximately 1 year
measure: Evoked potential amplitude
timeFrame: Approximately 1 year
measure: Frequency following response magnitude
timeFrame: Approximately 1 year
measure: Frequency following response timing
timeFrame: Approximately 1 year
measure: Ongoing electroencephalography power
timeFrame: Approximately 1 year
measure: Montreal Cognitive Assessment score
timeFrame: Approximately 1 year
measure: Reading Span
timeFrame: Approximately 1 year
measure: Hearing aid usage
timeFrame: Approximately 1 year
measure: Word-in-noise perception testing
timeFrame: Approximately 1 year
measure: Listening invested/required effort
timeFrame: Approximately 1 year
measure: Working memory testing
timeFrame: Approximately 1 year
measure: Glasgow Hearing Aid Benefit Profile (GHABP)
timeFrame: Approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Curtis J. Billings, PhD
role: PRINCIPAL_INVESTIGATOR
References: