Clinical trial NCT05796011: PET-CT-based Study of Central Mechanisms of Cortical Metabolism in 18F-FDG and 18F-AV1451 Age-related Deafness
Official title: PET-CT-based Study of Central Mechanisms of Cortical Metabolism in 18F-FDG and 18F-AV1451 Age-related Deafness: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Hearing Loss
PET-CT
Keywords: PET-CT
Age-related hearing loss
18F-FDG
18F-AV1451
Cortical metabolism
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants recruited were elderly subjects in the age range of 60-85 years, and normal controls, elderly deaf non-hearing aid group were collected according to the inclusion and exclusion criteria

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: pure tone average
timeFrame: through study completion, an average of 6 months
measure: Speech recognition score
timeFrame: through study completion, an average of 6 months
measure: MMSE score and grade
timeFrame: through study completion, an average of 6 months
measure: MoCA score and grade
timeFrame: through study completion, an average of 6 months
measure: Otorhinolaryngological diseases and daily life self-assessment questionnaire
timeFrame: through study completion, an average of 6 months
measure: Resting Electroencephalogram
timeFrame: through study completion, an average of 6 months
measure: Functional Near-Infrared Spectoscopy
timeFrame: through study completion, an average of 6 months
measure: Positron emmision tomography
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: