Back to resultsfNIRS, Listening Effort, and Motivation
Primary Purpose
Hearing Loss
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hearing aids (omnidirectional)
Hearing aids (directional)
Unaided
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria: Adults (18-99) years Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss Experienced hearing aid users Fluent in English Exclusion Criteria: Minors (17 years or less) Hearing status that did not fall within inclusion criteria Vulnerable populations
Sites / Locations
- Sonova Innovation Centre Toronto
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hearing loss
Arm Description
All participants will have hearing loss and be assigned to all three interventions. The interventions consist of aided-omnidirectional, aided-directional, and no hearing aids (no intervention).
Outcomes
Primary Outcome Measures
Oxygenation using functional near infrared spectroscopy (fNIRS)
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.
Response times
Response times will be defined as the amount of time between the beginning of a stimulus and when participants submit their responses.
Listening accuracy
Speech understanding in noise percent correct scores
Secondary Outcome Measures
Full Information
NCT ID
NCT05893992
First Posted
May 30, 2023
Last Updated
May 30, 2023
Sponsor
Sonova AG
Collaborators
Toronto Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT05893992
Brief Title
fNIRS, Listening Effort, and Motivation
Official Title
Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (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
Product Manufactured in and Exported from the U.S.
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. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to indicate what they heard using a closed-set response interface. Participants will complete 4 sessions: a training session, and a session for each condition. During each test session, participants will be instructed to listen to at least 100 sentences. Oxygenation, response times, and listening accuracy will be measured throughout.
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)
Masking Description
Investigator knows condition assignments; participant knows when they are wearing hearing aids and when they are not
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hearing loss
Arm Type
Experimental
Arm Description
All participants will have hearing loss and be assigned to all three interventions. The interventions consist of aided-omnidirectional, aided-directional, and no hearing aids (no intervention).
Intervention Type
Device
Intervention Name(s)
Hearing aids (omnidirectional)
Intervention Description
Device for hearing loss compensation with microphone sensitivity all around the listener.
Intervention Type
Device
Intervention Name(s)
Hearing aids (directional)
Intervention Description
Device for hearing loss compensation with microphone sensitivity in front of the listener.
Intervention Type
Other
Intervention Name(s)
Unaided
Other Intervention Name(s)
No hearing aids
Intervention Description
Control condition
Primary Outcome Measure Information:
Title
Oxygenation using functional near infrared spectroscopy (fNIRS)
Description
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.
Time Frame
Up to 1 hour during 1 session (per condition - for a total of 3 hours)
Title
Response times
Description
Response times will be defined as the amount of time between the beginning of a stimulus and when participants submit their responses.
Time Frame
Up to 1 hour during 1 session (per condition - for a total of 3 hours)
Title
Listening accuracy
Description
Speech understanding in noise percent correct scores
Time Frame
Up to 1 hour during 1 session (per condition - for a total of 3 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults (18-99) years
Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
Experienced hearing aid users
Fluent in English
Exclusion Criteria:
Minors (17 years or less)
Hearing status that did not fall within inclusion criteria
Vulnerable populations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Vaisberg, PhD
Phone
9057456785
Email
jonathan.vaisberg@sonova.com
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
IPD Sharing Plan Description
There is no plan to share individual participant data with other researchers.
Learn more about this trial
fNIRS, Listening Effort, and Motivation
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