NCT04284384

Brief Summary

This Doctor of Philosophy (PhD) project is part of a larger project on potentially modifiable risk factors for dementia in a life course perspective, with an overarching aim to improve prevention of dementia and thereby potentially relieve patient and caregiver distress and decrease societal load. The present PhD project will concentrate on confirming knowledge of HI as an independent risk factor for dementia and exploring potentially causative factors to explain this relationship.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,952

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

February 6, 2020

Last Update Submit

September 6, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Rate of dementia diagnosis in the HUNT 70+ study

    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).

    2017-2019

  • Rate of Minimal Cognitive Impairment (MCI) in the HUNT 70+ study

    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.

    2017-2019

  • Rate of cognitive impairment defined as age- and education-adjusted thresholds on cognitive assessments scales

    The participants have been assessed with the Montreal Cognitive Assessment scale and the ten-word recall test

    2017-2019

Study Arms (2)

HUNT4 70+

All inhabitants of Nord-Trøndelag 70 years of age or older were invited to participate in HUNT4 70+.

HUNT Trondheim 70+

All inhabitants of one district in Trondheim 70 years of age or older were invited to participate in HUNT4 70+.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Living in designated area

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian National Advisory Unit of Ageing and Health

Tønsberg, Norway

Location

Related Publications (3)

  • GjOra L, Strand BH, Bergh S, Borza T, Braekhus A, Engedal K, Johannessen A, Kvello-Alme M, Krokstad S, Livingston G, Matthews FE, Myrstad C, Skjellegrind H, Thingstad P, Aakhus E, Aam S, Selbaek G. Current and Future Prevalence Estimates of Mild Cognitive Impairment, Dementia, and Its Subtypes in a Population-Based Sample of People 70 Years and Older in Norway: The HUNT Study. J Alzheimers Dis. 2021;79(3):1213-1226. doi: 10.3233/JAD-201275.

    PMID: 33427745BACKGROUND
  • Myrstad C, Engdahl BL, Costafreda SG, Krokstad S, Livingston G, Selbaek G. Hearing and cognitive scores measured with the Montreal Cognitive Assessment Scale in The HUNT Study, Norway. Alzheimers Dement. 2025 Feb;21(2):e14514. doi: 10.1002/alz.14514. Epub 2025 Jan 23.

  • Myrstad C, Engdahl BL, Costafreda SG, Krokstad S, Lin F, Livingston G, Strand BH, Ohre B, Selbaek G. Hearing impairment and risk of dementia in The HUNT Study (HUNT4 70+): a Norwegian cohort study. EClinicalMedicine. 2023 Dec 4;66:102319. doi: 10.1016/j.eclinm.2023.102319. eCollection 2023 Dec.

MeSH Terms

Conditions

DementiaHearing Loss

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Geir Selbæk, PhD

    Norwegian Centre for Ageing and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 25, 2020

Study Start

August 19, 2019

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations