A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2028-03-09

Brief Summary

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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.

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Detailed Description

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Materials and methods: The unicentric, prospective cohort study included 388 patients with presbycusis aged 60-85 who were recruited in the Department of Otorhinolaryngology from March 2022 to March 2028. They were averagely divided into the control group (n = 194) and the intervention group (n = 194). The post intervention group received hearing aid intervention, and was followed up for 5 years, once every six months. Audiological assessment, cognitive function assessment, noninvasive brain imaging assessment and hearing aid effect assessment were performed at baseline and each follow-up. This thesis aim to investigate the changes of cognitive function in senile deafness under the intervention of hearing aids.

Conditions

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Age-related Hearing Loss Hearing Loss, Sensorineural Hearing Aid Cognitive Function Abnormal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group

Procedure: no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Procedure: a intervention via hearing aids for 5 years

Group Type ACTIVE_COMPARATOR

Hearing Aids

Intervention Type DEVICE

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

Interventions

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Hearing Aids

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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);

Exclusion Criteria

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes