Mild Cognitive ImpairmentNCT05336942
Correlation Between Prognosis of Mild Cognitive Impairment and Hearing Function in Community Elderly
An observational study of Mild Cognitive Impairment, run by Tongji University at 1 site in China.
Trial summary
Cognitive dysfunction is a high incidence disease in the elderly. To date, there is no effective treatment. At the same time, early cognitive impairment is easy to be ignored, delayed intervention. Most patients develop moderate or severe dementia with hearing loss before treatment. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Mar 2022
- 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 55 to 65 years
- All sexes
- Adult, Older adult
Study population: Mild cognitive impairment in the community
Who may be able to join
- The registered residence of local residents is more than one month.
- Aged 55 to 65 years.
- Be able to conduct verbal communication or written conversation, or complete the investigation with the help of family members.
Who cannot join
- Mini-mental state examination(MMSE), illiterate group ≤ 17 points, primary school group ≤ 20 points, middle school or above group 24 points;
- Those who meet the ICD-10 diagnostic criteria for dementia;
- Those who are obviously blind or have difficulty in speech expression;
- Persons suffering from serious physical diseases;
- Those who meet the diagnostic criteria of schizophrenia, neurosis, organic mental disorder and mental retardation;
- Persons with severe or above hearing impairment;
- Those who are unable to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mild Cognitive Impairment on Auditory System and Its Correlation With Cognitive Function: a Multicenter, Randomized Controlled Study
Cognitive dysfunction is a high incidence disease in the elderly. To date, there is no effective treatment. At the same time, early cognitive impairment is easy to be ignored, delayed intervention. Most patients develop moderate or severe dementia with hearing loss before treatment. At present, there are few studies on the correlation between mild cognitive impairment and hearing function. The investigators evaluated CDR, MMSE, MoCa, and hearing tests at baseline, 6 months later, and 12 months later in a multicenter, randomized cohort study of adults aged 55-65 years. To investigate the correlation between mild cognitive impairment and hearing impairment and its possible predictors. The investigators hope to provide more evidence-based evidence for early identification of mild cognitive impairment.
Read the detailed description
With the aging of society, the health of the elderly has paid more and more attention. Cognitive dysfunction has always been a common disease that seriously affects the quality of life of the elderly, thus increasing the burden of family and society. How to prevent and slow down cognitive dysfunction is a topic worthy of discussion, but so far, there is no safer and effective method to solve this problem.
Cognitive function refers to various conscious mental activities of human beings in the state of awakening, including reception function, namely receiving external information through various senses, memory and learning function, thinking function and expression function. Mild cognitive impairment (MCI) is the early stage of Senile dementia and a cognitive loss state between normal aging and dementia. The reception function of sensory organs is the basis of the whole cognitive activity and the initial stage of cognitive function, so there is a close relationship between sensation and cognitive function. Studies have shown that hearing impairment is an independent risk factor for cognitive impairment, hearing loss is positively correlated with cognitive impairment, and senile MCI is significantly correlated with hearing impairment, both of which exist a dose-effect relationship and complement each other. Especially in people over 50 years old, hearing impairment has a high incidence of cognitive impairment, and hearing impairment is an influential factor of cognitive function. There is a certain correlation between hearing loss and cognitive function. Bai Jie et al. analyzed the MMSE, MoCA, drawing clock test and daily living ability Assessment Scale of the normal hearing group and the untreated senile deafness group, and showed that hearing loss would lead to cognitive impairment, mainly for two reasons: (1) People with presbyopia do not have a good understanding of the tasks to be performed; (2) Presbyopia causes social isolation and cognitive decline.
American Medical Association (ASA) study included 1,884 subjects, of whom 1,162 had presbyage-related deafness, and the results showed that these patients had lower cognitive function than normal hearing subjects. They believe that the reason is that both senile deafness and cognitive decline occur in the same neural source. Therefore, it is worth exploring whether cognitive function can be delayed and improved by improving hearing. There are a large number of people over 60 years old with hearing impairment. According to the Chinese Epidemiological survey, 35-55% of people over 60 years old suffer from different degrees of hearing impairment. But as most of the older hearing impairment is a process of gradual development, thus can be considered as a immutable physiological process, and this is a kind of don't want to expose himself, and is hard to see someone invisible disability, therefore, are easily ignored by others, resulting in social communication, interpersonal communication between the obstacle, thus reducing the social function of old people.
To date, there are few prospective studies on the relationship between hearing impairment and cognitive impairment. This research through the community elderly were followed up for 1 year, evaluation of hearing loss and the correlation between prognosis of mild cognitive function impairment, focus on community elderly hearing impairment and the relationship between the cognitive dysfunction, to strengthen the science popularization of the old man, so that more older people can focus on listening and impaired cognitive function, active intervention, In this way, the quality of life of the elderly can be improved, social communication can be promoted, life satisfaction of the elderly can be improved, and family and social burden can be reduced.
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, auditory, cognitive function
- Medical subject headings
- Cognitive Dysfunction
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 |
|---|---|---|
| MCI-HI group | Mild cognitive impairment and hearing impairment group | |
| MCI-nHI group | Mild cognitive impairment and no hearing impairment group | |
| Control group | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental state examination (MMSE)
To screen and assess the extent of cognitive dysfunction.
Measured: Baseline
Mini-mental state examination (MMSE)
To screen and assess the extent of cognitive dysfunction.
Measured: 6-month
Mini-mental state examination (MMSE)
To screen and assess the extent of cognitive dysfunction.
Measured: 12-month
Montreal Cognitive Assessment (MocA)
To evaluate various domains of cognition.
Measured: Baseline
Montreal Cognitive Assessment (MocA)
To evaluate various domains of cognition.
Measured: 6-month
Montreal Cognitive Assessment (MocA)
To evaluate various domains of cognition.
Measured: 12-month
Pure tone Listening Test (PTA)
To determine the threshold intensity of hearing at each frequency and measure the nature and extent of hearing loss.
Measured: Baseline
Pure tone Listening Test (PTA)
To determine the threshold intensity of hearing at each frequency and measure the nature and extent of hearing loss.
Measured: 6-month
Pure tone Listening Test (PTA)
To determine the threshold intensity of hearing at each frequency and measure the nature and extent of hearing loss.
Measured: 12-month
Secondary outcomes (6)
Clinical Dementia Rating (CDR)
To generated to stage the severity of dementia.
Measured: Baseline
Clinical Dementia Rating (CDR)
To generated to stage the severity of dementia.
Measured: 6-month
Clinical Dementia Rating (CDR)
To generated to stage the severity of dementia.
Measured: 12-month
Auditory brainstem response (ABR)
To evaluate objectively the hearing level by the response threshold of V wave.
Measured: Baseline
Auditory brainstem response (ABR)
To evaluate objectively the hearing level by the response threshold of V wave.
Measured: 6-month
Auditory brainstem response (ABR)
To evaluate objectively the hearing level by the response threshold of V wave.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Nov 2020
- Primary completion30 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tong, Tongji University
- Investigators
- Jie Yuan, M.D., Principal investigator, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336942
- Sponsor's protocol ID
- PKJ2019-Y24
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Srikanth V, Sinclair AJ, Hill-Briggs F, Moran C, Biessels GJ. Type 2 diabetes and cognitive dysfunction-towards effective management of both comorbidities. Lancet Diabetes Endocrinol. 2020 Jun;8(6):535-545. doi: 10.1016/S2213-8587(20)30118-2.
PubMed 32445740Ringman JM, Medina LD, Rodriguez-Agudelo Y, Chavez M, Lu P, Cummings JL. Current concepts of mild cognitive impairment and their applicability to persons at-risk for familial Alzheimer's disease. Curr Alzheimer Res. 2009 Aug;6(4):341-6. doi: 10.2174/156720509788929336.
PubMed 19689233Heywood R, Gao Q, Nyunt MSZ, Feng L, Chong MS, Lim WS, Yap P, Lee TS, Yap KB, Wee SL, Ng TP. Hearing Loss and Risk of Mild Cognitive Impairment and Dementia: Findings from the Singapore Longitudinal Ageing Study. Dement Geriatr Cogn Disord. 2017;43(5-6):259-268. doi: 10.1159/000464281. Epub 2017 Apr 19.
PubMed 28420004Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: A Review Article. Am J Alzheimers Dis Other Demen. 2018 Dec;33(8):500-507. doi: 10.1177/1533317518791401. Epub 2018 Aug 1.
PubMed 30068225Maharani A, Pendleton N, Leroi I. Hearing Impairment, Loneliness, Social Isolation, and Cognitive Function: Longitudinal Analysis Using English Longitudinal Study on Ageing. Am J Geriatr Psychiatry. 2019 Dec;27(12):1348-1356. doi: 10.1016/j.jagp.2019.07.010. Epub 2019 Jul 22.
PubMed 31402088Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.
PubMed 23337978Khan HZ, Park CY, Lim MA, Beltran AJ, Farquhar D, Yencha M, Capra GG. Radiographic findings in young adults with asymmetric sensorineural hearing loss. Am J Otolaryngol. 2019 Jan-Feb;40(1):78-82. doi: 10.1016/j.amjoto.2018.10.003. Epub 2018 Oct 11.
PubMed 30472122Tong J, Zhang J, Xu L, Liu M, Min J, Yao M, Cheng X, Zhang Q, Sun X, Yuan J. Effect of hearing loss on cognitive function in patients with mild cognitive impairment: A prospective, randomized, and controlled study. Front Aging Neurosci. 2022 Aug 1;14:934921. doi: 10.3389/fnagi.2022.934921. eCollection 2022.
PubMed 35978946
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mild Cognitive Impairment on Auditory System and Its Correlation With Cognitive Function: a Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05336942
- Acronym / sponsor ID
- PKJ2019-Y24
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, auditory, cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 20 Apr 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.
Cognitive dysfunction is a high incidence disease in the elderly. To date, there is no effective treatment. At the same time, early cognitive impairment is easy to be ignored, delayed intervention. Most patients develop moderate or severe dementia with hearing loss before treatment. At present, there are few studies on the correlation between mild cognitive impairment and hearing function. The investigators evaluated CDR, MMSE, MoCa, and hearing tests at baseline, 6 months later, and 12 months later in a multicenter, randomized cohort study of adults aged 55-65 years. To investigate the correlation between mild cognitive impairment and hearing impairment and its possible predictors. The investigators hope to provide more evidence-based evidence for early identification of mild cognitive impairment.
Detailed description
With the aging of society, the health of the elderly has paid more and more attention. Cognitive dysfunction has always been a common disease that seriously affects the quality of life of the elderly, thus increasing the burden of family and society. How to prevent and slow down cognitive dysfunction is a topic worthy of discussion, but so far, there is no safer and effective method to solve this problem.
Cognitive function refers to various conscious mental activities of human beings in the state of awakening, including reception function, namely receiving external information through various senses, memory and learning function, thinking function and expression function. Mild cognitive impairment (MCI) is the early stage of Senile dementia and a cognitive loss state between normal aging and dementia. The reception function of sensory organs is the basis of the whole cognitive activity and the initial stage of cognitive function, so there is a close relationship between sensation and cognitive function. Studies have shown that hearing impairment is an independent risk factor for cognitive impairment, hearing loss is positively correlated with cognitive impairment, and senile MCI is significantly correlated with hearing impairment, both of which exist a dose-effect relationship and complement each other. Especially in people over 50 years old, hearing impairment has a high incidence of cognitive impairment, and hearing impairment is an influential factor of cognitive function. There is a certain correlation between hearing loss and cognitive function. Bai Jie et al. analyzed the MMSE, MoCA, drawing clock test and daily living ability Assessment Scale of the normal hearing group and the untreated senile deafness group, and showed that hearing loss would lead to cognitive impairment, mainly for two reasons: (1) People with presbyopia do not have a good understanding of the tasks to be performed; (2) Presbyopia causes social isolation and cognitive decline.
American Medical Association (ASA) study included 1,884 subjects, of whom 1,162 had presbyage-related deafness, and the results showed that these patients had lower cognitive function than normal hearing subjects. They believe that the reason is that both senile deafness and cognitive decline occur in the same neural source. Therefore, it is worth exploring whether cognitive function can be delayed and improved by improving hearing. There are a large number of people over 60 years old with hearing impairment. According to the Chinese Epidemiological survey, 35-55% of people over 60 years old suffer from different degrees of hearing impairment. But as most of the older hearing impairment is a process of gradual development, thus can be considered as a immutable physiological process, and this is a kind of don't want to expose himself, and is hard to see someone invisible disability, therefore, are easily ignored by others, resulting in social communication, interpersonal communication between the obstacle, thus reducing the social function of old people.
To date, there are few prospective studies on the relationship between hearing impairment and cognitive impairment. This research through the community elderly were followed up for 1 year, evaluation of hearing loss and the correlation between prognosis of mild cognitive function impairment, focus on community elderly hearing impairment and the relationship between the cognitive dysfunction, to strengthen the science popularization of the old man, so that more older people can focus on listening and impaired cognitive function, active intervention, In this way, the quality of life of the elderly can be improved, social communication can be promoted, life satisfaction of the elderly can be improved, and family and social burden can be reduced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MCI-HI group | – | –Mild cognitive impairment and hearing impairment group |
| MCI-nHI group | – | –Mild cognitive impairment and no hearing impairment group |
| Control group | – | –Control group |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mild cognitive impairment in the community
Key inclusion criteria (3 listed)
- The registered residence of local residents is more than one month.
- Aged 55 to 65 years.
- Be able to conduct verbal communication or written conversation, or complete the investigation with the help of family members.
Key exclusion criteria (7 listed)
- Mini-mental state examination(MMSE), illiterate group ≤ 17 points, primary school group ≤ 20 points, middle school or above group 24 points;
- Those who meet the ICD-10 diagnostic criteria for dementia;
- Those who are obviously blind or have difficulty in speech expression;
- Persons suffering from serious physical diseases;
- Those who meet the diagnostic criteria of schizophrenia, neurosis, organic mental disorder and mental retardation;
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
Mini-mental state examination (MMSE)
Time frame: Baseline
To screen and assess the extent of cognitive dysfunction.
Mini-mental state examination (MMSE)
Time frame: 6-month
To screen and assess the extent of cognitive dysfunction.
Mini-mental state examination (MMSE)
Time frame: 12-month
To screen and assess the extent of cognitive dysfunction.
Montreal Cognitive Assessment (MocA)
Time frame: Baseline
To evaluate various domains of cognition.
Montreal Cognitive Assessment (MocA)
Time frame: 6-month
To evaluate various domains of cognition.
Montreal Cognitive Assessment (MocA)
Time frame: 12-month
To evaluate various domains of cognition.
Pure tone Listening Test (PTA)
Time frame: Baseline
To determine the threshold intensity of hearing at each frequency and measure the nature and extent of hearing loss.
Pure tone Listening Test (PTA)
Time frame: 6-month
To determine the threshold intensity of hearing at each frequency and measure the nature and extent of hearing loss.
Pure tone Listening Test (PTA)
Time frame: 12-month
To determine the threshold intensity of hearing at each frequency and measure the nature and extent of hearing loss.
6 secondary outcomes
Clinical Dementia Rating (CDR)
Time frame: Baseline
Clinical Dementia Rating (CDR)
Time frame: 6-month
Clinical Dementia Rating (CDR)
Time frame: 12-month
Auditory brainstem response (ABR)
Time frame: Baseline
Auditory brainstem response (ABR)
Time frame: 6-month
Auditory brainstem response (ABR)
Time frame: 12-month
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 20 Apr 2022.
- Results publication: PubMed 32445740Srikanth V, Sinclair AJ, Hill-Briggs F, Moran C, Biessels GJ. Type 2 diabetes and cognitive dysfunction-towards effective management of both comorbidities. Lancet Diabetes Endocrinol. 2020 Jun;8(6):535-545. doi: 10.1016/S2213-8587(20)30118-2.
- Results publication: PubMed 19689233Ringman JM, Medina LD, Rodriguez-Agudelo Y, Chavez M, Lu P, Cummings JL. Current concepts of mild cognitive impairment and their applicability to persons at-risk for familial Alzheimer's disease. Curr Alzheimer Res. 2009 Aug;6(4):341-6. doi: 10.2174/156720509788929336.
- Results publication: PubMed 28420004Heywood R, Gao Q, Nyunt MSZ, Feng L, Chong MS, Lim WS, Yap P, Lee TS, Yap KB, Wee SL, Ng TP. Hearing Loss and Risk of Mild Cognitive Impairment and Dementia: Findings from the Singapore Longitudinal Ageing Study. Dement Geriatr Cogn Disord. 2017;43(5-6):259-268. doi: 10.1159/000464281. Epub 2017 Apr 19.
- Results publication: PubMed 30068225Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: A Review Article. Am J Alzheimers Dis Other Demen. 2018 Dec;33(8):500-507. doi: 10.1177/1533317518791401. Epub 2018 Aug 1.
- Results publication: PubMed 31402088Maharani A, Pendleton N, Leroi I. Hearing Impairment, Loneliness, Social Isolation, and Cognitive Function: Longitudinal Analysis Using English Longitudinal Study on Ageing. Am J Geriatr Psychiatry. 2019 Dec;27(12):1348-1356. doi: 10.1016/j.jagp.2019.07.010. Epub 2019 Jul 22.
- Results publication: PubMed 23337978Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.
- Results publication: PubMed 30472122Khan HZ, Park CY, Lim MA, Beltran AJ, Farquhar D, Yencha M, Capra GG. Radiographic findings in young adults with asymmetric sensorineural hearing loss. Am J Otolaryngol. 2019 Jan-Feb;40(1):78-82. doi: 10.1016/j.amjoto.2018.10.003. Epub 2018 Oct 11.
- Derived from this study: PubMed 35978946Tong J, Zhang J, Xu L, Liu M, Min J, Yao M, Cheng X, Zhang Q, Sun X, Yuan J. Effect of hearing loss on cognitive function in patients with mild cognitive impairment: A prospective, randomized, and controlled study. Front Aging Neurosci. 2022 Aug 1;14:934921. doi: 10.3389/fnagi.2022.934921. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jie Yuan, M.D. principal investigator
Tongji University
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 Mild Cognitive Impairment, run by Tongji University at 1 site in China.
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 3 inclusion and 7 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 20 Apr 2022. 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 China. 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?
Mini-mental state examination (MMSE) (time frame: Baseline). The study lists 9 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 NCT05336942, which also lists 8 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 20 Apr 2022.