Sleep DisturbanceNCT04207502
Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
An observational study of Sleep Disturbance and Cognitive Change, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Cognitive Change, Aging
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Sep 2019to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Chang Gung Memorial Hospital
Taipei, 105
CHUNG-HAO LIN, M.D.
- Recruiting
Chang Gung Health and Culture Village
Taoyuan City, 333
CHIH-MING LIN, M.D.
About this study
This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese.
Read the 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.
- Conditions
- Sleep Disturbance, Cognitive Change, Aging
- Keywords
- dementia, depression, brain structure, system biology
- Medical subject headings
- Parasomnias, Dementia, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: one night
Secondary outcomes (5)
The actigraphy of local Taiwanese aged over 60 years old
Measure the circadian rhythm (unit in minute) by Actiwatch
Measured: two weeks
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
Measured: one day
The gut microbiota of local Taiwanese aged over 60 years old
Assess the gut bacterial diversity and profile by stool analysis
Measured: one day
The metabolism of local Taiwanese aged over 60 years old
Measure the metabolites as biomarkers by urine and blood analysis
Measured: one day
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
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Sep 2019
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University
- Responsible party
- Sponsor
- Investigators
- JI-TSENG FANG, M.D., Study chair, Chang Gung Memorial HospitalNING-HUNG CHEN, M.D., Principal investigator, Chang Gung Memorial HospitalGENG-HAO LIU, M.D., Principal investigator, Chang Gung Memorial HospitalJUNG LUNG HSU, M.D., Principal investigator, Chang Gung Memorial HospitalSHWU-HUA LEE, M.D., Principal investigator, Chang Gung Memorial HospitalCHIH-MING LIN, M.D., Principal investigator, Chang Gung Memorial HospitalCHUNG-HAO LIN, M.D., Principal investigator, Chang Gung Memorial HospitalCHENG HONG TOH, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207502
- Sponsor's protocol ID
- CORPG3J0371
- Other IDs
- 201900702A3
- Status last verified
- Sep 2019
- First submitted
- 26 Nov 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41258815
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
- ClinicalTrials.gov ID
- NCT04207502
- Acronym / sponsor ID
- CORPG3J0371
- Conditions
- Sleep Disturbance, Cognitive Change, Aging
- Keywords
- dementia, depression, brain structure, system biology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
5 secondary outcomes
The actigraphy of local Taiwanese aged over 60 years old
Time frame: two weeks
The neurocognitive questionnaire of local Taiwanese aged over 60 years old
Time frame: one day
The gut microbiota of local Taiwanese aged over 60 years old
Time frame: one day
The metabolism of local Taiwanese aged over 60 years old
Time frame: one day
The polysomnographic recording for elderly with obstructive sleep apnea (OSA)
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 41258815Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JI-TSENG FANG, M.D. study chair
Chang Gung Memorial Hospital
NING-HUNG CHEN, M.D. principal investigator
Chang Gung Memorial Hospital
GENG-HAO LIU, M.D. principal investigator
Chang Gung Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbance and Cognitive Change, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JI-TSENG FANG, M.D. (+886-3-3281200 ext. 8181, fangjits@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The brain volume of local Taiwanese aged over 60 years old (time frame: one hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.