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

Sponsor
WSAUD A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05465564
Collaborator
(none)
200
Enrollment
1
Location
19.4
Anticipated Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing
    Actual Study Start Date :
    Feb 15, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. overall hearing aid satisfaction [6 months]

      minimum: 1, maximum: 10 ; the higher value indicates a better outcome

    2. IOI-HA [6 months]

      minimum: 7, maximum: 35; the higher value indicates a better outcome

    3. hearing aid satisfaction (Hearing-Related Lifestyle scale) [6 months]

      minimum: 1, maximum: 5; the higher value indicates a better outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dina Lelic Lynge DK Denmark 3540

    Sponsors and Collaborators

    • WSAUD A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    WSAUD A/S
    ClinicalTrials.gov Identifier:
    NCT05465564
    Other Study ID Numbers:
    • Hear_101
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness

    Study Results

    No Results Posted as of Jul 28, 2022