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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05892731
Other study ID # SYSKY-2023-424-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 8, 2023
Est. completion date December 31, 2023

Study information

Verified date January 2023
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date December 31, 2023
Est. primary completion date April 16, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years to 89 Years
Eligibility 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 Design


Intervention

Other:
with depression
age-related hearing loss with depression
without depression
age-related hearing loss without depression

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 score of Montreal Cognitive Assessment scale 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
Primary score of Mini-mental State Examination 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. 1 day of enrollment
Secondary pure tone average 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
Secondary speech acceptance threshold 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
Secondary Maximum speech recognition score 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
Secondary score of 15-item Geriatric Depression Scale 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
Secondary score of HAMD scale 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. 1 day of enrollment
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