Clinical trial NCT05892731: Study of Cognitive Reserve Disorder Affecting Depression in Aged Related Hearing Loss Via Rest State EEG
Official title: Study of Cognitive Reserve Disorder Affecting Depression in Age- Related Hearing Loss Via Rest State EEG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Hearing Loss
Cognitive Decline
Depression
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: score of Montreal Cognitive Assessment scale
timeFrame: 1 day of enrollment
measure: score of Mini-mental State Examination
timeFrame: 1 day of enrollment
Secondary outcomes:
measure: pure tone average
timeFrame: 1 day of enrollment
measure: speech acceptance threshold
timeFrame: 1 day of enrollment
measure: Maximum speech recognition score
timeFrame: 1 day of enrollment
measure: score of 15-item Geriatric Depression Scale
timeFrame: 1 day of enrollment
measure: score of HAMD scale
timeFrame: 1 day of enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: