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

Not Applicable

Recruiting

• Conditions: Hearing Loss, Sensorineural; Hearing Impairment, Sensorineural
• Interventions: Diagnostic Test: uAud; Diagnostic Test: Traditional audiometry

• Registration Number: NCT05043207
• Lead Sponsor: University of Southern Denmark

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-14
• Study Start: 2022-09-01
• Primary Completion: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uAud	uAud	Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.
control	Traditional audiometry	Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.

Primary Outcome Measures

Name	Time	Method
SSQ12 (Speech, Spatial & Qualities of Hearing scale)	3 months	A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.

Secondary Outcome Measures

Name	Time	Method
HINT (Hearing In Noise Test)	3 months	A performance test of patients speech intelligibility in noise.

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Funen, Denmark