NCT05694039

Brief Summary

Background: Deafness is one of the nine potentially modifiable risk factors for dementia simulated by the Lancet dementia Prevention, intervention and Care Committee in 2017. Some studies have found that the risk factors of dementia in deafness system, with the increase of the degree of deafness, the risk of cognitive decline increases, while after long-term wear of hearing aids, the deterioration of immediate and delayed memory is less, and the possibility of cognitive decline slows down. Therefore, it is necessary for us to improve the auditory ability of patients with deafness through auditory intervention, so as to slow down its effect on dementia and reduce the incidence of dementia. At present, auditory intervention methods include hearing aid wearing and cochlear implant. However, there are few studies on cognitive function of presbycusis patients in China, and there is no research on how many years of auditory intervention can effectively slow down the incidence of dementia in presbycusis patients with MCI. Therefore, we intend to conduct a prospective cohort study on the changes of cognitive function of presbycusis under hearing aid intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress69%
Mar 2022Mar 2028

Study Start

First participant enrolled

March 9, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2028

Last Updated

January 23, 2023

Status Verified

March 1, 2022

Enrollment Period

6 years

First QC Date

January 12, 2023

Last Update Submit

January 20, 2023

Conditions

Age-related Hearing LossHearing Loss, SensorineuralHearing AidCognitive Function Abnormal

Outcome Measures

Primary Outcomes (2)

  • MoCA

    Montreal Cognitive Assessment is an assessment tool for rapid screening of cognitive dysfunction.

    half a year

  • MMSE

    Mini-mental State Examination is currently the preferred scale for cognitive impairment screening and is widely used in dementia screening.

    half a year

Secondary Outcomes (2)

  • Pure Tone Audiometry

    half a year

  • Speeeh Audlometry

    half a year

Other Outcomes (3)

  • EEG/ERP

    half a year

  • fNIRS

    half a year

  • Hearing Aid Assessment composite

    half a year

Study Arms (2)

Control Group

NO INTERVENTION

Procedure: no intervention

Intervention Group

ACTIVE COMPARATOR

Procedure: a intervention via hearing aids for 5 years

Device: Hearing Aids

Interventions

Hearing AidsDEVICE

The intervention group uses hearing aids, and the intervention group receives hearing aid intervention for 5 years.

Intervention Group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>60yrs，≤85yrs（MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79,and25.2% for80-84）; Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL, and the PTA ≤ 90 dB HL; Diagnosed as Presbycusis; Score of 23 or below on Mini-Mental Status Exam (MMSE); Score of 22 or below on Montreal Cognitive Assessment (MoCA);

You may not qualify if:

  • Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss); Significant history of otologic or neurologic disorders; Hearing loss remediated with a cochlear implant (cannot wear hearing aids); Any clinically significant unstable or progressive medical condition; Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

PresbycusisHearing Loss, SensorineuralCognition Disorders

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Central Study Contacts

Minqian Gao, B.sc

CONTACT

13660778861gaomq6@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

March 9, 2022

Primary Completion (Estimated)

March 9, 2028

Study Completion (Estimated)

March 9, 2028

Last Updated

January 23, 2023

Record last verified: 2022-03

Locations

CN(1)