fNIRs, Listening Effort, and Speech Intelligibility
Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedSeptember 13, 2022
March 1, 2022
6 months
April 8, 2022
September 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Up to 2 hours during 1 session
Speech-in-noise performance
Number of words repeatedly correctly for a given listening condition.
Up to 2 hours during 1 session
Study Arms (1)
Participants with hearing loss.
EXPERIMENTALParticipants with hearing loss.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults (18-99 years) with ≥3 months hearing aid experience
- binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss
- fluent in English
You may not qualify if:
- children/teenagers
- normal hearing or hearing loss exceeding N6 (severe) by 10 dB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
- Toronto Metropolitan Universitycollaborator
Study Sites (1)
Sonova Innovation Centre Toronto
Mississauga, Ontario, L5L1J3, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinyu Qian, PhD
Sonova AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 15, 2022
Study Start
May 3, 2022
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
September 13, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share