Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss

NCT ID: NCT07074769

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2025-08-28

Brief Summary

Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.

Detailed Description

This primary objective is to evaluate whether the device improves speech recognition in noise compared to the clinically relevant comparison condition of no treatment (unaided) for adults with mild to moderate hearing loss. The primary outcome will be measured using a clinically available test of speech recognition in noise that uses adaptive bracketing of signal to noise ratio (the Matrix test). The secondary outcome will also assess speech recognition in babble at ecologically valid fixed signal to babble ratios (The Connected Speech Test). Tertiary outcomes will examine device users' ratings of listening effort in noise with and without the device.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A prospective in-lab within-subjects design with repeated measures

Test of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device.

Group Type: EXPERIMENTAL

Evaluation of speech-in-noise intelligibility and listening effort

Intervention Type: DEVICE

The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire

Interventions

Evaluation of speech-in-noise intelligibility and listening effort

The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 years and older
• symmetrical bilateral mild to moderate sensorineural hearing loss
• native speakers of English.

Exclusion Criteria

• Children
• those without hearing loss
• those without symmetrical bilateral mild to moderate sensorineural hearing loss
• those who do not wish to wear the test device instead of their own spectacles during the in-lab procedure
• those who are not native speakers of English
• those who have pacemakers, other implantable devices, or insulin pumps

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

Luxottica Group S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

Protocol version 4 9.6.2025

Identifier Type: -

Identifier Source: org_study_id