Hearing ImpairmentNCT05465564
My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing
An observational study of Hearing Impairment and Hearing Loss, run by WSAUD A/S at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment, Hearing Loss
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: First-time hearing aid users
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hearing Impairment, Hearing Loss
- Medical subject headings
- Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
overall hearing aid satisfaction
minimum: 1, maximum: 10 ; the higher value indicates a better outcome
Measured: 6 months
IOI-HA
minimum: 7, maximum: 35; the higher value indicates a better outcome
Measured: 6 months
hearing aid satisfaction (Hearing-Related Lifestyle scale)
minimum: 1, maximum: 5; the higher value indicates a better outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Feb 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- WSAUD A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465564
- Sponsor's protocol ID
- Hear_101
- Status last verified
- Dec 2023
- First submitted
- 15 Jul 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing
- ClinicalTrials.gov ID
- NCT05465564
- Acronym / sponsor ID
- Hear_101
- Conditions
- Hearing Impairment, Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- WSAUD A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First-time hearing aid users
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall hearing aid satisfaction
Time frame: 6 months
minimum: 1, maximum: 10 ; the higher value indicates a better outcome
IOI-HA
Time frame: 6 months
minimum: 7, maximum: 35; the higher value indicates a better outcome
hearing aid satisfaction (Hearing-Related Lifestyle scale)
Time frame: 6 months
minimum: 1, maximum: 5; the higher value indicates a better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Impairment and Hearing Loss, run by WSAUD A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall hearing aid satisfaction (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.