fNIRS, Listening Effort, and Motivation

NCT ID: NCT05893992

Last Updated: 2025-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-23

Study Completion Date

2024-12-31

Brief Summary

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The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to repeat the word that they heard and rate how much subjective listening effort was required in order to make out the words. fNIRS will be measured throughout. Participants will complete the task using a hearing aid program intended for listening in quiet, and a hearing aid program with new advanced noise management features.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

A single cohort of participants will receive and be assessed in all treatment/intervention
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Digital noise management, then quiet listening

Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments.

Group Type EXPERIMENTAL

Hearing aids with noise management features for listening in noise

Intervention Type DEVICE

Device for hearing loss compensation with digital noise management features

Hearing aid for listening in quiet environments

Intervention Type DEVICE

Device for hearing loss compensation for listening in quiet environments

Quiet listening, then digital noise management

Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features.

Group Type EXPERIMENTAL

Hearing aids with noise management features for listening in noise

Intervention Type DEVICE

Device for hearing loss compensation with digital noise management features

Hearing aid for listening in quiet environments

Intervention Type DEVICE

Device for hearing loss compensation for listening in quiet environments

Interventions

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Hearing aids with noise management features for listening in noise

Device for hearing loss compensation with digital noise management features

Intervention Type DEVICE

Hearing aid for listening in quiet environments

Device for hearing loss compensation for listening in quiet environments

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults (18-99) years
* Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
* Fluent in English

Exclusion Criteria

* Minors (17 years or less)
* Not able to tolerate wearing of hearing aids
* Vulnerable populations
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toronto Metropolitan University

OTHER

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinyu Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova Innovation Centre Toronto

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-15557

Identifier Type: -

Identifier Source: org_study_id

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