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NCT Number: NCT05694039

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

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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Key information

Conditions

Age-related Hearing Loss Cognition Disorders Cognitive Function Abnormal Ear Diseases Hearing Aid Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Minqian Gao, B.sc

CONTACT

[email protected]

13660778861

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hearing aids

Device

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

Primary outcomes

  1. MoCA

    Time frame: half a year

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

  2. MMSE

    Time frame: half a year

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

Secondary outcomes

  1. Pure Tone Audiometry

    Time frame: 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

    Time frame: 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 outcomes

  1. EEG/ERP

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Minqian Gao, B.sc

CONTACT

[email protected]

13660778861

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2023
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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