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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05330585
Other study ID # SRF-1412
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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