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

Hearing Loss, Sensorineural Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043207
• Other study ID #: UAUD
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Southern Denmark
• Contact: Carl Pedersen, master's degree
• Phone: +4531314965
• Email: pede[@]sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz.
• Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL.
• Danish native speaker.
• No previous experience with HAs.
• Capable of answering questionnaires through an online mailbox. Exclusion criteria
• Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies.
• Treatment affected by conductive hearing loss (air-bone gap >10 dB on more than one frequency below 1 kHz).
• Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs.
• Ear, nose, or throat surgery in the past 12 months.
• Evidence that the participant has made minor use of the HAs during the study (e.g., < 2h per day).
• Visual or motor impairment that might affect the use of the UAud system.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment, Sensorineural
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Diagnostic Test:
• uAud
Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
• Traditional audiometry
Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Funen

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Innovation Fund Denmark, William Demant Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IOI-HA (International Outcome Inventory for Hearing Aids)	A questionnaire regarding the patient's own perception of hearing aid outcome.	3 months
Other	APHAB (Abbreviated Profile of Hearing Aid Benefit).	A questionnaire regarding the patient's own perception of hearing and hearing aid outcome.	3 months
Other	HINT-U (Hearing In Noise test - under amplification)	A variation of the HINT framework targeting potential under amplification of hearing aid sound level.	3 months.
Other	HINT-O (Hearing In Noise Test - Over amplification)	A variation of the HINT framework targeting potential over amplification of hearing aid sound level.	3 months.
Primary	SSQ12 (Speech, Spatial & Qualities of Hearing scale)	A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.	3 months
Secondary	HINT (Hearing In Noise Test)	A performance test of patients speech intelligibility in noise.	3 months