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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: with depression
age-related hearing loss with depression
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.
Other: without depression
age-related hearing loss without depression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
1 day of enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
1 day of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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