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

NCT05796011 | Unknown

• 1 other identifier: SYSKY-2022-139-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Hearing Loss; PET-CT

Keywords

PET-CT; Age-related hearing loss; 18F-FDG; 18F-AV1451; Cortical metabolism

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

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

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

Device: hearing aids

Age-related hearing loss patients without an hearing aid

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

Other: without hearing intervention

Elderly healthy control

healthy elderly with normal hearing tested by pure tone audiometry.

Other: healthy control

Interventions

hearing aids DEVICE

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

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

without hearing intervention OTHER

neither earing aids nor other heaing treatment were applied.

Age-related hearing loss patients without an hearing aid

healthy control OTHER

healthy control

Elderly healthy control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Presbycusis

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Central Study Contacts

Minqian Gao, B.Sc

CONTACT

13660778861; gaomq6@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: July 6, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-02

Locations

CN (1)