Clinical trial NCT04207502: Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
Official title: Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disturbance
Cognitive Change
Aging
Keywords: dementia
depression
brain structure
system biology
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
First posted: 2019-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 subjects with aged over 60 years old participated in annual health checkup conducted by either Taipei city or Chang Gung Health and Culture Village.

Brief summary: This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese.

Detailed description: This project is the pilot for the basis of establishing the schema of database and efficient procedures including subject recruitment, specimen collection, management, and measurement of samples obtained from multiple sources. We will focus on deciphering the correlation of sleep quality and the integrity of brain structure by integrating the holistic health data, socio-demographic characteristics, MRI, wearable technique, and laboratory technology including clinical lab, genotyping, metabolomics, gut microbiome, to unravel the clinical feature of which the age will effect on the frequency of sleep disturbance. This project will not only systematically study the aging effect on the sleep quality and brain structure integrity, but pave the way for exploring a variety of aging-related indications.

Eligibility criteria: Inclusion Criteria:

* Participants of annual health checkup conducted by either Taipei city or Chang Gung Health and Culture Village.
* aged ≧ 60 years old.
* have medical record in Chang Gung Memorial Hospital.
* resided in the Taiwan area over 180 days in past one year.

Exclusion Criteria:

* Participants with the medical history of severe organ disorders, severe autoimmune disease, or cancer under treatment.
* Contraindications or previously failure for receiving brain computerized tomography or magnetic resonance imaging scan.
* Participants who had receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation.
* Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
* Difficulty in communication or disabilities

Primary outcomes:
measure: The brain volume of local Taiwanese aged over 60 years old
timeFrame: one hour
measure: The monitoring of sleep-related events of local Taiwanese aged over 60 years old
timeFrame: one night
Secondary outcomes:
measure: The actigraphy of local Taiwanese aged over 60 years old
timeFrame: two weeks
measure: The neurocognitive questionnaire of local Taiwanese aged over 60 years old
timeFrame: one day
measure: The gut microbiota of local Taiwanese aged over 60 years old
timeFrame: one day
measure: The metabolism of local Taiwanese aged over 60 years old
timeFrame: one day
measure: The polysomnographic recording for elderly with obstructive sleep apnea (OSA)
timeFrame: three months
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Health and Culture Village
Study officials:
affiliation: Chang Gung Memorial Hospital
name: JI-TSENG FANG, M.D.
role: STUDY_CHAIR
affiliation: Chang Gung Memorial Hospital
name: NING-HUNG CHEN, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: GENG-HAO LIU, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: JUNG LUNG HSU, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: SHWU-HUA LEE, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: CHIH-MING LIN, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: CHUNG-HAO LIN, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: CHENG HONG TOH, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: CHENG-HSUN CHIU, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung University
name: MEI-LING CHENG, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: