- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284384
Hearing Impairment as a Risk Factor for Dementia in Older Adults
Modifiable Risk Factors and Dementia - A Study Examining the Association Between Hearing Impairment in Mid-life and Cognitive Impairment in the HUNT4 70+ Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tønsberg, Norway
- Norwegian National Advisory Unit of Ageing and Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
HUNT2 and HUNT4 hearing studies: Participants from 17 of the 24 municipalities in the county were offered and accepted a hearing examination, consisting of pure-tone audiometry and two questionnaires on hearing issues, such as use of hearing aids, noise exposure, and tinnitus.
HUNT4 70+/HUNT Trondheim 70+: All participants 70 years of age or older are invited to participate in HUNT4 70+ including cognitive screening examinations.
Description
Inclusion Criteria:
- Living in designated area
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HUNT4 70+
All inhabitants of Nord-Trøndelag 70 years of age or older were invited to participate in HUNT4 70+.
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HUNT Trondheim 70+
All inhabitants of one district in Trondheim 70 years of age or older were invited to participate in HUNT4 70+.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of dementia diagnosis in the HUNT 70+ study
Time Frame: 2017-2019
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Two clinical and scientific experts will independently set at diagnosis of cognitive impairment or dementia based on all available information applying standard diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).
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2017-2019
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Rate of Minimal Cognitive Impairment (MCI) in the HUNT 70+ study
Time Frame: 2017-2019
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Two clinical and scientific experts will independently set at diagnosis of cognitive impairment or dementia based on all available information applying standard diagnostic criteria DSM-5.
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2017-2019
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Rate of cognitive impairment defined as age- and education-adjusted thresholds on cognitive assessments scales
Time Frame: 2017-2019
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The participants have been assessed with the Montreal Cognitive Assessment scale and the ten-word recall test
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2017-2019
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Geir Selbæk, PhD, Norwegian Centre for Ageing and Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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