NCT04207502

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 26, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

November 26, 2019

Last Update Submit

December 24, 2019

Conditions

Sleep DisturbanceCognitive ChangeAging

Keywords

dementiadepressionbrain structuresystem biology

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • The actigraphy of local Taiwanese aged over 60 years old

    two weeks

  • The neurocognitive questionnaire of local Taiwanese aged over 60 years old

    one day

  • The gut microbiota of local Taiwanese aged over 60 years old

    one day

  • The metabolism of local Taiwanese aged over 60 years old

    one day

  • The polysomnographic recording for elderly with obstructive sleep apnea (OSA)

    three months

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taipei Chang Gung Memorial Hospital

Taipei, 105, Taiwan

RECRUITING

Chang Gung Health and Culture Village

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (1)

  • Liu GH, Huang YH, Yuan TC, Chen YP, Hsu JL, Lee SH, Lin CM, Toh CH, Fang JT, Lin SW, Chuang LP, Chen NH. Associations of Wearable-Measured Sleep and Physical Activity With Memory Performance in Older Adults: Cross-Sectional Study With Actigraphy and MRI. JMIR Aging. 2025 Dec 9;8:e80584. doi: 10.2196/80584.

    PMID: 41258815DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, and stool

MeSH Terms

Conditions

ParasomniasDementiaDepression

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersBehavioral SymptomsBehavior

Study Officials

  • JI-TSENG FANG, M.D.

    Chang Gung Memorial Hospital

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JI-TSENG FANG, M.D.

CONTACT

+886-3-3281200fangjits@cgmh.org.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 23, 2019

Study Start

September 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

December 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)