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Completed

NCT Number: NCT05893992

fNIRS, Listening Effort, and Motivation

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova Innovation Centre Toronto

Mississauga, Ontario, L5L1J3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing aids with noise management features for listening in noise

Device

Device for hearing loss compensation with digital noise management features

Hearing aid for listening in quiet environments

Device

Device for hearing loss compensation for listening in quiet environments

Primary outcomes

  1. 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.

Secondary outcomes

  1. Listening Accuracy

    Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours

    Speech understanding in noise percent correct scores

  2. 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Toronto Metropolitan University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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