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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207502
• Other study ID #: CORPG3J0371
• Secondary ID: 201900702A3
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: August 2020

Study information

• Verified date: September 2019
• Source: Chang Gung Memorial Hospital
• Contact: JI-TSENG FANG, M.D.
• Phone: +886-3-3281200
• Email: fangjits[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Change
• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Locations

Country	Name	City	State
Taiwan	Taipei Chang Gung Memorial Hospital	Taipei City
Taiwan	Chang Gung Health and Culture Village	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The brain volume of local Taiwanese aged over 60 years old	Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging (MRI)	one hour
Primary	The monitoring of sleep-related events of local Taiwanese aged over 60 years old	Measure the sleep stages (unit in minute), apnea-hypopnea index (unit in counts/hour), and respiratory events by polysomnography	one night
Secondary	The actigraphy of local Taiwanese aged over 60 years old	Measure the circadian rhythm (unit in minute) by Actiwatch	two weeks
Secondary	The neurocognitive questionnaire of local Taiwanese aged over 60 years old	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	one day
Secondary	The gut microbiota of local Taiwanese aged over 60 years old	Assess the gut bacterial diversity and profile by stool analysis	one day
Secondary	The metabolism of local Taiwanese aged over 60 years old	Measure the metabolites as biomarkers by urine and blood analysis	one day
Secondary	The polysomnographic recording for elderly with obstructive sleep apnea (OSA)	Subjects with OSA will undergo continuous positive airway pressure (CPAP) and evaluate the improvement rate (unit in percent) by polysomnography and sleepiness questionnaire	three months