NCT03279510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

August 23, 2017

Last Update Submit

March 23, 2023

Conditions

Hearing Loss

Keywords

auditory perceptionhearing

Outcome Measures

Primary Outcomes (12)

  • Evoked potential latency

    Latency will be measured in milliseconds

    Approximately 1 year

  • Evoked potential amplitude

    Amplitude will be measured in microvolts

    Approximately 1 year

  • Frequency following response magnitude

    Magnitude of response measured in nanovolts

    Approximately 1 year

  • Frequency following response timing

    Timing measured by cross-correlation between stimulus and response

    Approximately 1 year

  • Ongoing electroencephalography power

    EEG power as a function of frequency recorded during words-in-noise measure

    Approximately 1 year

  • Montreal Cognitive Assessment score

    Assessment score from 1 to 30

    Approximately 1 year

  • Reading Span

    Percent correct recall on working memory task

    Approximately 1 year

  • Hearing aid usage

    Data logging from the hearing aid will provide usage in hours per day

    Approximately 1 year

  • 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

  • Listening invested/required effort

    Participants' rating of the effort required (0-9) and invested (0-9) for listening task

    Approximately 1 year

  • Working memory testing

    Performance on auditory working memory task

    Approximately 1 year

  • 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

Study Arms (1)

Hearing aids

EXPERIMENTAL

All study participants will be fit with hearing aids.

Device: hearing aids

Interventions

hearing aidsDEVICE

Subjects are fit with hearing aids.

Hearing aids

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Curtis J. Billings, PhD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 12, 2017

Study Start

March 22, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)