NCT05336942

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

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

November 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

April 9, 2022

Last Update Submit

April 14, 2022

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairmentauditorycognitive function

Outcome Measures

Primary Outcomes (9)

  • Mini-mental state examination (MMSE)

    To screen and assess the extent of cognitive dysfunction.

    Baseline

  • Mini-mental state examination (MMSE)

    To screen and assess the extent of cognitive dysfunction.

    6-month

  • Mini-mental state examination (MMSE)

    To screen and assess the extent of cognitive dysfunction.

    12-month

  • Montreal Cognitive Assessment (MocA)

    To evaluate various domains of cognition.

    Baseline

  • Montreal Cognitive Assessment (MocA)

    To evaluate various domains of cognition.

    6-month

  • Montreal Cognitive Assessment (MocA)

    To evaluate various domains of cognition.

    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.

    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.

    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.

    12-month

Secondary Outcomes (6)

  • Clinical Dementia Rating (CDR)

    Baseline

  • Clinical Dementia Rating (CDR)

    6-month

  • Clinical Dementia Rating (CDR)

    12-month

  • Auditory brainstem response (ABR)

    Baseline

  • Auditory brainstem response (ABR)

    6-month

  • +1 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mild cognitive impairment in the community

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji University

Shanghai, China

Location

Related Publications (8)

  • 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.

    PMID: 32445740RESULT

  • Ringman 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.

    PMID: 19689233RESULT

  • Heywood 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.

    PMID: 28420004RESULT

  • Jongsiriyanyong 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.

    PMID: 30068225RESULT

  • Maharani 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.

    PMID: 31402088RESULT

  • Lin 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.

    PMID: 23337978RESULT

  • Khan 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.

    PMID: 30472122RESULT

  • Tong 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.

    PMID: 35978946DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jie Yuan, M.D.

    Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2022

First Posted

April 20, 2022

Study Start

November 1, 2020

Primary Completion

December 30, 2021

Study Completion

March 30, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

CN(1)