fNIRs, Listening Effort, and Speech Intelligibility

Hearing Loss Clinical Trial

Official title:

Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05330585
• Other study ID #: SRF-1412
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Sonova AG
• Contact: n/a
• 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. 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.

Description:

See above.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults (18-99 years) with =3 months hearing aid experience

• binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss

• fluent in English

Exclusion Criteria:

• children/teenagers

• normal hearing or hearing loss exceeding N6 (severe) by 10 dB

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Hearing aids
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.

Other:
• Unaided
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.

Locations

Country	Name	City	State
Canada	Sonova Innovation Centre Toronto	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Speech-in-noise performance	Number of words repeatedly correctly for a given listening condition.	Up to 2 hours during 1 session