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

Age-related Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796011
• Other study ID #: SYSKY-2022-139-01
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Minqian Gao, B.Sc
• Phone: 13660778861
• Email: gaomq6[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Hearing Loss
• Deafness
• Hearing Loss
• PET-CT
• Presbycusis

Intervention

Device:
• hearing aids
Hearing aid(s) fitted for one or two sides of ear.

Other:
• without hearing intervention
neither earing aids nor other heaing treatment were applied.
• healthy control
healthy control

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pure tone average	The pure tone hearing threshold of each octave was tested under standard test conditions. Pure tone average(PTA, an average air conductance threshold of 500, 1000, 2000 and 4000Hz) and high frequence pure tone average(HF-PTA, an average air conductance threshold of 2000, 4000 and 8000Hz) were calculated for analysis	through study completion, an average of 6 months
Primary	Speech recognition score	Speech recognition score was tested under standard test conditions.The stimulus material is a two-syllable word list of Mandarin speech audiometry materials.	through study completion, an average of 6 months
Primary	MMSE score and grade	The scale is divided into seven aspects, including time orientation, place orientation, immediate memory, attention and gauging, delayed memory, language and visual space. There are 30 items in the scale, with a total score of 30. Normal 27 to 30, mild cognitive impairment 21 to 26, moderate cognitive impairment 10 to 20, and severe cognitive impairment 0 to 9.	through study completion, an average of 6 months
Primary	MoCA score and grade	Montreal Cognitive Assessment (Montreal Cognitive Assessment) is a rapid screening tool for abnormal cognitive function. The scoring criteria were: 26 to 30 points for normal cognitive impairment, 18 to 25 points for mild cognitive impairment, 10 to 17 points for moderate cognitive impairment, and 0 to 9 points for severe cognitive impairment.	through study completion, an average of 6 months
Primary	Otorhinolaryngological diseases and daily life self-assessment questionnaire	The questionnaire included otitis media, tinnitus, deafness, ear pain, ear tightness, ear leakage, ear itching, course of disease, severity of self-complaint, etc	through study completion, an average of 6 months
Primary	Resting Electroencephalogram	Electroencephalogram (EEG) is applied to collect the spontaneous and rhythmic biologic potential data of the subjects' resting brain, namely, 8-minute resting state data with their eyes closed without any visual or auditory stimulation, in a dark environment.	through study completion, an average of 6 months
Primary	Functional Near-Infrared Spectoscopy	Functional near-infrared Spectoscopy(fNIRS) is used to collect the changes of oxygenated hemoglobin and deoxygenated hemoglobin in the temporal lobe of a subject during brain activity by using a portable Near Infrared optical signal analysis system from Shimadsu, Japan.	through study completion, an average of 6 months
Primary	Positron emmision tomography	Pet-ct, Positron emmision tomography is adopted by Siemens PET/CT integrated machine in Germany.	through study completion, an average of 6 months