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NCT05465564 Clinical Trial

My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

Hearing Loss Clinical Trial

Official title:
My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05465564
Other study ID # Hear_101
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date December 30, 2023

Study information
Verified date December 2023
Source WSAUD A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary purpose of this study is to investigate how personality, motivation & auditory lifestyle relate to hearing aid satisfaction & acceptance for first-time hearing aid users. As such, first-time hearing aid users will be followed via an app for a period of six months. They will answer baseline questionnaires about personality, lifestyle and hearing aid expectations before the first fit. After the hearing aid fitting, they will be prompted by the app to answer questionnaires about their hearing aid experience at weeks 2, 4, 8, 12, 16, 20 and 24.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 18-85 years of age - Sensorineural hearing loss within the hearing aid's fitting range - Fluency in local language - First-time hearing aid user - Experienced smartphone and app user - Must sign the informed consent Exclusion Criteria: - Severe cognitive impairment that would preclude the ability to perform the necessary tasks (as judged by the HCP) - Inability for the TPs to travel to the clinic during the study period - Complex hearing disorders such as Ménière's

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Dina Lelic Lynge DK

Sponsors (1)
Lead Sponsor Collaborator
WSAUD A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall hearing aid satisfaction minimum: 1, maximum: 10 ; the higher value indicates a better outcome 6 months
Primary IOI-HA minimum: 7, maximum: 35; the higher value indicates a better outcome 6 months
Primary hearing aid satisfaction (Hearing-Related Lifestyle scale) minimum: 1, maximum: 5; the higher value indicates a better outcome 6 months
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