DementiaNCT04284384
Hearing Impairment as a Risk Factor for Dementia in Older Adults
An observational study of Dementia and Hearing Loss, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Hearing Loss
- How many people
- 6,952 participants
- Where
- 1 siteNorway
- Study dates
- 19 Aug 2019to 20 Nov 2020
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Living in designated area
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifiable Risk Factors and Dementia - A Study Examining the Association Between Hearing Impairment in Mid-life and Cognitive Impairment in the HUNT4 70+ Study
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.
Read the detailed description
Despite a huge increase in the knowledge about disease mechanisms in various types of dementia in recent years, no curative treatment exists at present. Results from research on disease-modifying agents have been disappointing. This has led to an increased interest in other ways to reduce the prevalence of dementia. A recent report estimated that up to one third of dementia cases could be delayed or prevented by interventions directed at the most common risk factors. In the "Lancet commission on dementia prevention, treatment, and care", hearing impairment (HI) was identified as the potentially most important modifiable risk factor. Even though HI is considered an important modifiable risk factor, the evidence regarding the association between HI and dementia risk is still limited.
- Conditions
- Dementia, Hearing Loss
- Medical subject headings
- Dementia, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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+. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 2017-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start19 Aug 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- 6,952 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, The Nord-Trøndelag Health Study, The Norwegian Institute of Public Health, University College London Hospitals, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Geir Selbæk, PhD, Principal investigator, Norwegian Centre for Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284384
- Sponsor's protocol ID
- 181009
- Status last verified
- Sep 2021
- First submitted
- 6 Feb 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33427745Myrstad 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.
PubMed 39846386Myrstad 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.
PubMed 38192588
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiable Risk Factors and Dementia - A Study Examining the Association Between Hearing Impairment in Mid-life and Cognitive Impairment in the HUNT4 70+ Study
- ClinicalTrials.gov ID
- NCT04284384
- Acronym / sponsor ID
- 181009
- Conditions
- Dementia, Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,952 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, The Nord-Trøndelag Health Study, The Norwegian Institute of Public Health, University College London Hospitals, University of Oslo
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 25 Feb 2020 (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.
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.
Detailed description
Despite a huge increase in the knowledge about disease mechanisms in various types of dementia in recent years, no curative treatment exists at present. Results from research on disease-modifying agents have been disappointing. This has led to an increased interest in other ways to reduce the prevalence of dementia. A recent report estimated that up to one third of dementia cases could be delayed or prevented by interventions directed at the most common risk factors. In the "Lancet commission on dementia prevention, treatment, and care", hearing impairment (HI) was identified as the potentially most important modifiable risk factor. Even though HI is considered an important modifiable risk factor, the evidence regarding the association between HI and dementia risk is still limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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+. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Living in designated area
Key exclusion criteria (1 listed)
- None
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
Rate of dementia diagnosis in the HUNT 70+ study
Time frame: 2017-2019
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).
Rate of Minimal Cognitive Impairment (MCI) in the HUNT 70+ study
Time frame: 2017-2019
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.
Rate of cognitive impairment defined as age- and education-adjusted thresholds on cognitive assessments scales
Time frame: 2017-2019
The participants have been assessed with the Montreal Cognitive Assessment scale and the ten-word recall test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 33427745GjOra 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.
- Derived from this study: PubMed 39846386Myrstad 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.
- Derived from this study: PubMed 38192588Myrstad 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.
- Individual participant dataSharing planned: No
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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.
Geir Selbæk, PhD principal investigator
Norwegian Centre for Ageing and Health
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 Dementia and Hearing Loss, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Sep 2021. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of dementia diagnosis in the HUNT 70+ study (time frame: 2017-2019). 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?
On the ClinicalTrials.gov record for NCT04284384, which also lists 3 linked publications.
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 14 Sep 2021.