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

December 24, 2019 updated by: Chang Gung Memorial Hospital
This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese.

Study Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei City, Taiwan, 105
        • Recruiting
        • Taipei Chang Gung Memorial hospital
        • Contact:
          • CHUNG-HAO LIN, M.D.
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Health and Culture Village
        • Contact:
          • CHIH-MING LIN, M.D.

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

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The actigraphy of local Taiwanese aged over 60 years old
Time Frame: two weeks
Measure the circadian rhythm (unit in minute) by Actiwatch
two weeks
The neurocognitive questionnaire of local Taiwanese aged over 60 years old
Time Frame: 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
one day
The gut microbiota of local Taiwanese aged over 60 years old
Time Frame: one day
Assess the gut bacterial diversity and profile by stool analysis
one day
The metabolism of local Taiwanese aged over 60 years old
Time Frame: one day
Measure the metabolites as biomarkers by urine and blood analysis
one day
The polysomnographic recording for elderly with obstructive sleep apnea (OSA)
Time Frame: 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
three months

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Chair: JI-TSENG FANG, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: NING-HUNG CHEN, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: GENG-HAO LIU, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: JUNG LUNG HSU, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: SHWU-HUA LEE, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: CHIH-MING LIN, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: CHUNG-HAO LIN, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: CHENG HONG TOH, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: CHENG-HSUN CHIU, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: MEI-LING CHENG, Ph.D., Chang Gung 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)

September 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CORPG3J0371
  • 201900702A3 (Other Identifier: Chang Gung Medical Foundation)

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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