- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892731
Study of Cognitive Reserve Disorder Affecting Depression in Aged Related Hearing Loss Via Rest State EEG
June 6, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study of Cognitive Reserve Disorder Affecting Depression in Age- Related Hearing Loss Via Rest State EEG
In this study, patients with aged-related hearing loss with depression and without depression were evaluated by audiometry (pure tone audiometry and speech audiometry), cognitive function assessment (MMSE scale for simple mental state test, MoCA Scale for Montreal Cognitive Assessment), and depressive symptoms assessment (GDS-15 and HAMD), resting state EEG.
The ananlysis of resting state EEG included power spectral density, traceability analysis, functional connectivity, microstate, clustering coefficient, characteristic path length, characteristic path permeability, and compatibility coefficient.
EEG signals were used to explore the activation of brain regions and poor connectivity of brain regions affected by cognitive reserve dissonance on the level of brain imaging.
This paper innovatively explores the influence of cognitive reserve dissonance on depressive mood in senile deafness by means of audiological assessment, cognitive function assessment, depression symptom assessment, resting state electroencephalography (EEG) and other technical means.
Auditory and cognitive cortical activation, functional connectivity of brain regions, small-world attributes and microstates were analyzed in senile deafness with or without depression at the brain imaging level.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
In this study, patients with aged-related hearing loss with depression and without depression were evaluated by audiometry (pure tone audiometry and speech audiometry), cognitive function assessment (MMSE scale for simple mental state test, MoCA Scale for Montreal Cognitive Assessment), and depressive symptoms assessment (GDS-15 and HAMD), resting state EEG.
The ananlysis of resting state EEG included power spectral density, traceability analysis, functional connectivity, microstate, clustering coefficient, characteristic path length, characteristic path permeability, and compatibility coefficient.
EEG signals were used to explore the activation of brain regions and poor connectivity of brain regions affected by cognitive reserve dissonance on the level of brain imaging.
This paper innovatively explores the influence of cognitive reserve dissonance on depressive mood in senile deafness by means of audiological assessment, cognitive function assessment, depression symptom assessment, resting state electroencephalography (EEG) and other technical means.
Auditory and cognitive cortical activation, functional connectivity of brain regions, small-world attributes and microstates were analyzed in senile deafness with or without depression at the brain imaging level.
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
In this study, PASS 15.0 was used to calculate the sample size, and the number of cases was arranged in a 1:1 ratio.
The test efficacy was 1-β = 0.9, the test level was α = 0.05, σ=3.0.
17 cases were required in each group.
Considering the 20% shedding rate, 22 cases were required in each group.
Consequently, 44 cases of age-related hearing loss were included in this study.
Description
Inclusion Criteria:
- age ≥55 years, < 90 years;
- For patients diagnosed with senile deafness, refering to Expert Consensus on Diagnosis and Intervention of Senile Hearing Loss, 2019 edition.
- mild, moderate, moderate and severe sensorineural hearing loss;
- Chinese who can cooperate with all Chinese version evaluation;
- right-handed;
- there was no middle ear disease or inner ear disease;
- there was no bilateral symmetry or sensorineural deafness;
- there was no severe neurological disease, serious systemic disease, family genetic history, or severe mental disease;
- there was no experience of hearing aids fitting.
Exclusion Criteria:
- pure tone audiometry suggests that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is > 91dB HL;
- sensorineural hearing loss caused by noise or drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
age-related hearing loss with depression
According to Hamilton depression scale, age-related hearing loss patients were divided into two groups, namely age-related hearing loss with depression and age-related hearing loss without depression.
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age-related hearing loss with depression
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age-related hearing loss without depression
According to Hamilton depression scale, age-related hearing loss patients were divided into two groups, namely age-related hearing loss with depression and age-related hearing loss without depression.
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age-related hearing loss without depression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
score of Montreal Cognitive Assessment scale
Time Frame: 1 day of enrollment
|
The Montreal Cognitive Assessment Scale(MoCA) is an assessment tool used to rapidly screen for cognitive abnormalities.
The test included 11 tests in eight cognitive areas, including attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation, and orientation.
Total score of 30 points, and the score of high school/technical secondary school or below needs to be added 1 point.
Level: Normal 26-30 , mild cognitive impairment(MCI) 18-25, moderate cognitive impairment 10-17, severe cognitive impairment 0-9.
|
1 day of enrollment
|
score of Mini-mental State Examination
Time Frame: 1 day of enrollment
|
Mini-mental State Examination (MMSE) is a scale for screening cognitive impairment and is widely used in dementia screening.
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.
The scale is 27 to 30 points normal, 21 to 26 points mild cognitive impairment, 10 to 20 points moderate cognitive impairment, and 0 to 9 points severe cognitive impairment.
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1 day of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pure tone average
Time Frame: 1 day of enrollment
|
With the national standard of hearing soundproof room, using Denmark international hearing AC40 pure tone audiometer, Hugson-westlake (HW) method was used to test the bilateral air conduction of 125Hz to 8000Hz and bone conduction of 500Hz to 4000Hz.
And its average pure tone hearing threshold PTA (the average value of gas conductance at 500Hz, 1000Hz, 2000Hz, 4000Hz) was obtained.
Level: normal, PTA≤25dB HL; mild HL, PTA=26-40dB HL; moderate HL PTA=41-55dB HL; moderate to severe, PTA= 56-70dB HL; severe, PTA=71-90dB HL; profound, PTA≥91dB HL(WHO1980)
|
1 day of enrollment
|
speech acceptance threshold
Time Frame: 1 day of enrollment
|
Speech audiometry is a kind of audiometry which uses standardized speech signals as acoustic stimuli to test the speech recognition ability of subjects.
The minimum sound intensity required by the tester to achieve 50% accuracy in the speech test is recorded as the threshold of speech acceptance threshold.
|
1 day of enrollment
|
Maximum speech recognition score
Time Frame: 1 day of enrollment
|
Speech audiometry is a kind of audiometry which uses standardized speech signals as acoustic stimuli to test the speech recognition ability of subjects.
In the test, the maximum accuracy at 30-40dB HL above PTA threshold was recorded as the maximum speech recognition score.
|
1 day of enrollment
|
score of 15-item Geriatric Depression Scale
Time Frame: 1 day of enrollment
|
15-item Geriatric Depression Scale (GDS-15) scores ≥6 were classified as having depressive mood, 0-5 as having no depressive mood, 6-9 as mildly depressed, and 10-12 as severely depressed mood.
|
1 day of enrollment
|
score of HAMD scale
Time Frame: 1 day of enrollment
|
For the 24th version of HAMD depression Scale, the total score > 35 May indicate severe depression; 21-35, may be mild to moderate depression; 9-20, suspected depression; < 8 indicates normal.
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1 day of enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2023
Primary Completion (Actual)
April 16, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
May 25, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 7, 2023
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Nervous System Diseases
- Mood Disorders
- Neurologic Manifestations
- Neurocognitive Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Cognition Disorders
- Sensation Disorders
- Hearing Disorders
- Hearing Loss, Sensorineural
- Depression
- Depressive Disorder
- Cognitive Dysfunction
- Hearing Loss
- Deafness
- Presbycusis
Other Study ID Numbers
- SYSKY-2023-424-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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