NCT05893992

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 repeat the word that they heard and rate how much subjective listening effort was required in order to make out the words. fNIRS will be measured throughout. Participants will complete the task using a hearing aid program intended for listening in quiet, and a hearing aid program with new advanced noise management features.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 23, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 17, 2025

Completed
Last Updated

August 17, 2025

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

May 30, 2023

Results QC Date

June 13, 2025

Last Update Submit

July 28, 2025

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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.

    Session 1, 2, 3 and 4; assessed for up to 2 hours

Secondary Outcomes (2)

  • Listening Accuracy

    Session 1, 2, 3 and 4; assessed for up to 2 hours

  • Subjective Listening Effort Rating

    Session 1, 2, 3 and 4; assessed for up to 2 hours

Study Arms (2)

Digital noise management, then quiet listening

EXPERIMENTAL

Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments.

Device: Hearing aids with noise management features for listening in noiseDevice: Hearing aid for listening in quiet environments

Quiet listening, then digital noise management

EXPERIMENTAL

Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features.

Device: Hearing aids with noise management features for listening in noiseDevice: Hearing aid for listening in quiet environments

Interventions

Hearing aids with noise management features for listening in noiseDEVICE

Device for hearing loss compensation with digital noise management features

Digital noise management, then quiet listeningQuiet listening, then digital noise management
Hearing aid for listening in quiet environmentsDEVICE

Device for hearing loss compensation for listening in quiet environments

Digital noise management, then quiet listeningQuiet listening, then digital noise management

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18-99) years
  • Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
  • Fluent in English

You may not qualify if:

  • Minors (17 years or less)
  • Not able to tolerate wearing of hearing aids
  • Vulnerable populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova Innovation Centre Toronto

Mississauga, Ontario, L5L1J3, Canada

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing AidsAuscultation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory AidsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Jonathan Vaisberg
Organization
Sonova
jonathan.vaisberg@sonova.com
9057456785

Study Officials

  • Jinyu Qian, PhD

    Sonova AG

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: A single cohort of participants will receive and be assessed in all treatment/intervention
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

September 23, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 17, 2025

Results First Posted

August 17, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data with other researchers.

Locations

CA(1)