NCT05043207

A Study Protocol for the Validation of UAud in a Clinical Setting.

A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Detailed description

The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination. Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Conditions

• Hearing Loss, Sensorineural
• Hearing Impairment, Sensorineural

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	uAud	Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
DIAGNOSTIC_TEST	Traditional audiometry	Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2024-12-01
• First posted: 2021-09-14
• Last updated: 2023-11-15

Locations

1 site across 1 country: Denmark