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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hearing Aids

    Device

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

Treatment groups

388 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MoCA

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

Time frame
half a year
2

MMSE

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

Time frame
half a year

Secondary outcomes

1

Pure Tone Audiometry

Pure audiometry is to measure the air conduction hearing thresholds of 125Hz, 250Hz, 500Hz, 1000Hz, 2000Hz, 4000Hz and 8000Hz and bone conduction threshold of 500Hz, 1000Hz, 2000Hz and 4000Hz in normal people and deaf patients by Hughson-Westlake(HW) method, also gets the tested person's pure-tone average (PTA) in the hearing ear which is calculated using thresholds for 0.5, 1, 2 and 4 kHz. The acoustic standard of the sound insulation room is GB/T16296, the reverberation time is (0.3±0.15) seconds, and the pure tone audiometer model is Interacoustics AC40(Inter-c AC40).

Time frame
half a year
2

Speeeh Audlometry

Speech audiometry is a kind of audiometry method that uses standardized speech signals as sound stimulation to test the speech recognition ability of subjects.

Time frame
half a year

Other outcomes

1

EEG/ERP

Electroencephalograph ( EEG power in alpha band) is record which reflects regular electric action of brain cells groups by the 128-channel EEG analyzer of EGI Company, USA, with its matching electrode cap, of which transverse axis represents time, and vertical y-axis represents value of potential generated by brain cells.

Time frame
half a year
2

fNIRS

Functional Near Infrared Spectroscopy uses fNIRS signal to measure the magnetic changes caused by the change of hemoglobin concentration in the process of brain cognitive activity at the level of brain imaging, so as to obtain BOLD signal.

Time frame
half a year
3

Hearing Aid Assessment composite

The assessment of hearing aid effect includes Chinese Version Hearing Handicap Inventory for the Elderly Screening(CHHIE-S), Abbreviated Profile of Hearing Aid Benefit(APHAB), Satisfaction with Amplification in DailyLife(SADL) and International Outcome Items for Hearing Aids(IOI-HA).

Time frame
half a year

Sponsors and contacts

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