Age-related Hearing LossNCT05796011
PET-CT-based Study of Central Mechanisms of Cortical Metabolism in 18F-FDG and 18F-AV1451 Age-related Deafness
An observational study of Age-related Hearing Loss and PET-CT, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Hearing Loss, PET-CT
- What is being tested?
- hearing aids and without hearing intervention
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Minqian Gao, B.sc, 13660778861, gaomq6@mail.sysu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Age-related Hearing Loss, PET-CT
- Being tested
- hearing aids, without hearing intervention, healthy control
- Keywords
- PET-CT, Age-related hearing loss, 18F-FDG, 18F-AV1451, Cortical metabolism
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aidsDevice
Hearing aid(s) fitted for one or two sides of ear.
without hearing interventionOther
neither earing aids nor other heaing treatment were applied.
healthy controlOther
healthy control
| Study group | Role | What they receive |
|---|---|---|
| Age-related hearing loss patients with hearing aid(s) | Age-related hearing loss patients who were fitted with at least one hearing aid. Receives: Device: hearing aids | |
| Age-related hearing loss patients without an hearing aid | Age-related hearing loss patients who were treated without hearing intervention. Receives: Other: without hearing intervention | |
| Elderly healthy control | healthy elderly with normal hearing tested by pure tone audiometry. Receives: Other: healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start6 Jul 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing LossStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796011
- Sponsor's protocol ID
- SYSKY-2022-139-01
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05796011
- Acronym / sponsor ID
- SYSKY-2022-139-01
- Conditions
- Age-related Hearing Loss, PET-CT
- Keywords
- PET-CT, Age-related hearing loss, 18F-FDG, 18F-AV1451, Cortical metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age-related hearing loss patients with hearing aid(s) | – | Device: hearing aidsAge-related hearing loss patients who were fitted with at least one hearing aid. |
| Age-related hearing loss patients without an hearing aid | – | Other: without hearing interventionAge-related hearing loss patients who were treated without hearing intervention. |
| Elderly healthy control | – | Other: healthy controlhealthy elderly with normal hearing tested by pure tone audiometry. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hearing aidsHearing aid(s) fitted for one or two sides of ear. | Device | Age-related hearing loss patients with hearing aid(s) |
| without hearing interventionneither earing aids nor other heaing treatment were applied. | Other | Age-related hearing loss patients without an hearing aid |
| healthy controlhealthy control | Other | Elderly healthy control |
Primary outcome
pure tone average
Time frame: through study completion, an average of 6 months
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
Speech recognition score
Time frame: through study completion, an average of 6 months
Speech recognition score was tested under standard test conditions.The stimulus material is a two-syllable word list of Mandarin speech audiometry materials.
MMSE score and grade
Time frame: through study completion, an average of 6 months
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.
MoCA score and grade
Time frame: through study completion, an average of 6 months
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.
Otorhinolaryngological diseases and daily life self-assessment questionnaire
Time frame: through study completion, an average of 6 months
The questionnaire included otitis media, tinnitus, deafness, ear pain, ear tightness, ear leakage, ear itching, course of disease, severity of self-complaint, etc
Resting Electroencephalogram
Time frame: through study completion, an average of 6 months
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.
Functional Near-Infrared Spectoscopy
Time frame: through study completion, an average of 6 months
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.
Positron emmision tomography
Time frame: through study completion, an average of 6 months
Pet-ct, Positron emmision tomography is adopted by Siemens PET/CT integrated machine in Germany.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Hearing Loss and PET-CT, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minqian Gao, B.Sc (13660778861, gaomq6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pure tone average (time frame: through study completion, an average of 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.