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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary


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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing Aids

Detailed Description

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.

Study Design

Study Type:
Anticipated Enrollment :
388 participants
Intervention Model:
Parallel Assignment
Double (Participant, Outcomes Assessor)
Primary Purpose:
Official Title:
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Mar 9, 2028
Anticipated Study Completion Date :
Mar 9, 2028

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

Procedure: no intervention

Active Comparator: Intervention Group

Procedure: a intervention via hearing aids for 5 years

Device: Hearing Aids
The intervention group uses hearing aids, and the intervention group receives hearing aid intervention for 5 years.

Outcome Measures

Primary Outcome Measures

  1. MoCA [half a year]

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

  2. MMSE [half a year]

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

Secondary Outcome Measures

  1. Pure Tone Audiometry [half a year]

    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).

  2. Speeeh Audlometry [half a year]

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

Other Outcome Measures

  1. EEG/ERP [half a year]

    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.

  2. fNIRS [half a year]

    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.

  3. Hearing Aid Assessment composite [half a year]

    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).

Eligibility Criteria


Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • SunYatsenU2H_YangH02
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023