fNIRs, Listening Effort, and Speech Intelligibility

September 12, 2022 updated by: Sonova AG

Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss

The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB) both without and with hearing aids set to a directional mode. The procedure will be a within-subject repeated measures. Stimuli will be randomized.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

See above.

Study Type

Interventional

Enrollment (Anticipated)

30

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18-99 years) with ≥3 months hearing aid experience
  • binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss
  • fluent in English

Exclusion Criteria:

  • children/teenagers
  • normal hearing or hearing loss exceeding N6 (severe) by 10 dB

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Participants with hearing loss.
Device: Hearing aids
Participants will listen to stimuli in the environment while wearing hearing aids which should make the stimuli more audible. Speech in noise performance is expected to improve and PFC oxygenation is expected to be reduced in this condition.
Other Names:
  • Investigational
Other: Unaided
Participants will listen to stimuli in the environment with their hearing loss. Speech in noise performance is expected to decline and PFC oxygenation is expected to be increased in this condition.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Listening effort
Time Frame: Up to 2 hours during 1 session
Listening effort inferred from infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. A higher concentration is indicative of more listening effort.
Up to 2 hours during 1 session
Speech-in-noise performance
Time Frame: Up to 2 hours during 1 session
Number of words repeatedly correctly for a given listening condition.
Up to 2 hours during 1 session

Collaborators and Investigators

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

Sponsor

Sonova AG

Collaborators

Ryerson University

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)

May 3, 2022

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (ACTUAL)

April 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-1412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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