Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging

• Conditions: Cognitive Change; Aging; Sleep Disturbance

• Registration Number: NCT04207502
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-01
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The monitoring of sleep-related events of local Taiwanese aged over 60 years old	one night	Measure the sleep stages (unit in minute), apnea-hypopnea index (unit in counts/hour), and respiratory events by polysomnography
The brain volume of local Taiwanese aged over 60 years old	one hour	Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
The actigraphy of local Taiwanese aged over 60 years old	two weeks	Measure the circadian rhythm (unit in minute) by Actiwatch
The gut microbiota of local Taiwanese aged over 60 years old	one day	Assess the gut bacterial diversity and profile by stool analysis
The neurocognitive questionnaire of local Taiwanese aged over 60 years old	one day	Measure the neurocognitive condition and sleep quality as assessed by GDS-15, UCLA-LS, HAM-A, HAM-D, AES, TSII, CTQ, AD8, MMSE, ECog, CERAD-NAB, PSQI, ESS, SOS, and STOP-Bang
The metabolism of local Taiwanese aged over 60 years old	one day	Measure the metabolites as biomarkers by urine and blood analysis
The polysomnographic recording for elderly with obstructive sleep apnea (OSA)	three months	Subjects with OSA will undergo continuous positive airway pressure (CPAP) and evaluate the improvement rate (unit in percent) by polysomnography and sleepiness questionnaire

Trial Locations

Locations (2)

Chang Gung Health and Culture Village; 🇨🇳 Taoyuan City, Taiwan

Taipei Chang Gung Memorial Hospital; 🇨🇳 Taipei City, Taiwan