fNIRS, Listening Effort, and Motivation

July 28, 2025 updated by: Sonova AG

Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5L1J3
        • Sonova Innovation Centre Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Hearing aids with noise management features for listening in noise
Device for hearing loss compensation with digital noise management features
Device: Hearing aid for listening in quiet environments
Device for hearing loss compensation for listening in quiet environments
Experimental: 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.
Device: Hearing aids with noise management features for listening in noise
Device for hearing loss compensation with digital noise management features
Device: Hearing aid for listening in quiet environments
Device for hearing loss compensation for listening in quiet environments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS)
Time Frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.
Session 1, 2, 3 and 4; assessed for up to 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Listening Accuracy
Time Frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
Speech understanding in noise percent correct scores
Session 1, 2, 3 and 4; assessed for up to 2 hours
Subjective Listening Effort Rating
Time Frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required.
Session 1, 2, 3 and 4; assessed for up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Collaborators

Toronto Metropolitan University

Investigators

  • Principal Investigator: Jinyu Qian, PhD, Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-15557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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