My Hearing Experience - a Study About the Effect of Perso... | NCT05465564

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

NCT05465564

Sponsor

WSAUD A/S

Status

Unknown status

Last Update Posted

Dec 20, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Hearing Impairment
Hearing Loss

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Jul 15, 2022

First Submission Date that Met QC Criteria

Jul 15, 2022

First Posted Date

Jul 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Dec 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

First-time hearing aid users

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dina Lelic		Lynge	DK	3540	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided