- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207502
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
Conditions
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
- Name: JI-TSENG FANG, M.D.
- Phone Number: 8181 +886-3-3281200
- Email: fangjits@cgmh.org.tw
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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