fNIRS, Listening Effort, and Motivation

Not Applicable

Not yet recruiting

• Conditions: Hearing Loss
• Interventions: Device: Hearing aids (omnidirectional); Device: Hearing aids (directional); Other: Unaided

• Registration Number: NCT05893992
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08
• Study Start: 2023-08
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hearing loss	Hearing aids (directional)	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).
Hearing loss	Hearing aids (omnidirectional)	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).
Hearing loss	Unaided	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).

Primary Outcome Measures

Name	Time	Method
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.
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.
Listening accuracy	Up to 1 hour during 1 session (per condition - for a total of 3 hours)	Speech understanding in noise percent correct scores

Trial Locations

Locations (1)

Sonova Innovation Centre Toronto; 🇨🇦 Mississauga, Ontario, Canada