An observational study in Age-related Hearing Loss and PET-CT, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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.
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.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 123 across 20 observational studies indexed under Presbycusis.
Browse Presbycusis studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Age-related hearing loss patients who were fitted with at least one hearing aid.
Device: hearing aids
Age-related hearing loss patients who were treated without hearing intervention.
Other: without hearing intervention
healthy elderly with normal hearing tested by pure tone audiometry.
Other: healthy control
Hearing aid(s) fitted for one or two sides of ear.
neither earing aids nor other heaing treatment were applied.
healthy control
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 6 months
Plan to share: Undecided
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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