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fNIRS, Listening Effort, and Motivation

Sponsor
Sonova AG (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893992
Collaborator
Toronto Metropolitan University (Other)
37
Enrollment
1
Location
1
Arm
6
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing aids (omnidirectional)
  • Device: Hearing aids (directional)
  • Other: Unaided
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
37 participants
Allocation:
N/A
Intervention 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
Primary Purpose:
Basic Science
Official Title:
Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hearing loss

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).

Device: Hearing aids (omnidirectional)
Device for hearing loss compensation with microphone sensitivity all around the listener.

Device: Hearing aids (directional)
Device for hearing loss compensation with microphone sensitivity in front of the listener.

Other: Unaided
Control condition
Other Names:
  • No hearing aids

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oxygenation using functional near infrared spectroscopy (fNIRS) [Up to 1 hour during 1 session (per condition - for a total of 3 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.

    2. Response times [Up to 1 hour during 1 session (per condition - for a total of 3 hours)]

      Response times will be defined as the amount of time between the beginning of a stimulus and when participants submit their responses.

    3. Listening accuracy [Up to 1 hour during 1 session (per condition - for a total of 3 hours)]

      Speech understanding in noise percent correct scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sonova Innovation Centre Toronto Mississauga Ontario Canada L5L1J3

    Sponsors and Collaborators

    • Sonova AG
    • Toronto Metropolitan University

    Investigators

    • Principal Investigator: Jinyu Qian, PhD, Sonova AG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sonova AG
    ClinicalTrials.gov Identifier:
    NCT05893992
    Other Study ID Numbers:
    • SRF-15557
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hearing Loss

    Study Results

    No Results Posted as of Jun 8, 2023