PET-CT-based Study of Central Mechanisms of Cortical Metabolism in 18F-FDG and 18F-AV1451 Age-related Deafness

NCT ID: NCT05796011

Last Updated: 2023-04-03

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-06

Study Completion Date

2024-01-01

Brief Summary

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The participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments, cognitive function assessments, non-invasive brain imaging, behavioral assessments were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. The project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.

Detailed Description

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The participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments (pure tone audiometry, speech audiometry), cognitive function assessments (Simple Mental State Examination MMSE scale, Montreal Cognitive Assessment Scale MoCA scale), non-invasive brain imaging (functional near-infrared spectroscopy fNIRS, EEG/ERP), behavioral assessments (functional near-infrared spectroscopy fNIRS, EEG/ERP, PET/CT, etc.) were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. The project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.

Conditions

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Age-related Hearing Loss PET-CT

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Age-related hearing loss patients with hearing aid(s)

Age-related hearing loss patients who were fitted with at least one hearing aid.

hearing aids

Intervention Type DEVICE

Hearing aid(s) fitted for one or two sides of ear.

Age-related hearing loss patients without an hearing aid

Age-related hearing loss patients who were treated without hearing intervention.

without hearing intervention

Intervention Type OTHER

neither earing aids nor other heaing treatment were applied.

Elderly healthy control

healthy elderly with normal hearing tested by pure tone audiometry.

healthy control

Intervention Type OTHER

healthy control

Interventions

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hearing aids

Hearing aid(s) fitted for one or two sides of ear.

Intervention Type DEVICE

without hearing intervention

neither earing aids nor other heaing treatment were applied.

Intervention Type OTHER

healthy control

healthy control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age\>50yrs,≤85yrs;
* Normal control group: normal hearing, no MCI, i.e. mean air conduction hearing threshold (0.5, 1, 2, 4 kHz) \< 25 dB HL, no air-bone conduction difference, MMSE score of 27-30; MoCA (corrected for educational attainment) score of 26-30;
* Elderly deafness without hearing aid group: patients diagnosed with elderly deafness, i.e. as a symmetrical, slowly progressive, binaural occurrence with age. hearing loss and reduced speech recognition with predominantly high frequency hearing involvement in the first place, with reference to the Expert Consensus on the Diagnosis and Intervention of Hearing Loss in the Elderly 2019 edition, mean air conduction threshold (PTA) \> 25 dB HL, mean air conduction hearing threshold at high frequency (HF-PTA) \> 25 dB HL, no poor air bone conduction, and no previous hearing aid use.
* No major neurological disorders, serious systemic diseases, family history of genetic predisposition, major psychological disorders.

Exclusion Criteria

* Pure tone audiometric cues with an average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) \> 91dB HL.
* Excluding diseases such as noise deafness and drug-induced deafness.
* Basic information is incomplete.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minqian Gao, B.Sc

Role: CONTACT

13660778861

Facility Contacts

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Minqian Gao, B.sc

Role: primary

13660778861

Other Identifiers

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SYSKY-2022-139-01

Identifier Type: -

Identifier Source: org_study_id

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