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fNIRs, Listening Effort, and Speech Intelligibility

Primary Purpose

Hearing Loss

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hearing aids
Unaided
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova Innovation Centre Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with hearing loss.

Arm Description

Participants with hearing loss.

Outcomes

Primary Outcome Measures

Listening effort
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.
Speech-in-noise performance
Number of words repeatedly correctly for a given listening condition.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2022
Last Updated
September 12, 2022
Sponsor
Sonova AG
Collaborators
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT05330585
Brief Title
fNIRs, Listening Effort, and Speech Intelligibility
Official Title
Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with hearing loss.
Arm Type
Experimental
Arm Description
Participants with hearing loss.
Intervention Type
Device
Intervention Name(s)
Hearing aids
Other Intervention Name(s)
Investigational
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Unaided
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Listening effort
Description
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.
Time Frame
Up to 2 hours during 1 session
Title
Speech-in-noise performance
Description
Number of words repeatedly correctly for a given listening condition.
Time Frame
Up to 2 hours during 1 session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyu Qian, PhD
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova Innovation Centre Toronto
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L1J3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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fNIRs, Listening Effort, and Speech Intelligibility

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