fNIRS, Listening Effort, and Motivation

Hearing Loss Clinical Trial

Official title:

Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05893992
• Other study ID #: SRF-15557
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: February 2024

Study information

• Verified date: May 2023
• Source: Sonova AG
• Contact: Jonathan Vaisberg, PhD
• Phone: 9057456785
• Email: jonathan.vaisberg[@]sonova.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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

Other:
• Unaided
Control condition

Locations

Country	Name	City	State
Canada	Sonova Innovation Centre Toronto	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Toronto Metropolitan University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 hour during 1 session (per condition - for a total of 3 hours)
Primary	Response times	Response times will be defined as the amount of time between the beginning of a stimulus and when participants submit their responses.	Up to 1 hour during 1 session (per condition - for a total of 3 hours)
Primary	Listening accuracy	Speech understanding in noise percent correct scores	Up to 1 hour during 1 session (per condition - for a total of 3 hours)