Sleep DisturbanceNCT07414680
Integrating Systematic Data of Medicine to Explore the Solution for Healthy Aging (ISDHA) Phase 4
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 health database of geriatric medicine for middle-aged and elderly people in Taiwan. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Cognitive Change, Aging
- How many people
- 250 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 Sep 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: By collecting data from participants in the "Integrating Systemic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrating Systemic Geriatric Medical Information to Explore Solutions for Healthy Aging" main project, and the "Integrating Systemic Medical Information to Explore Solutions for Healthy Aging" project, approximately 100 individuals aged 60 and above, residing in Songshan District of Taipei City, Chang Gung Health and Wellness Village, and Senior Citizens' Health Activity Centers (Shuanglian, New Taipei City; Delai, Taoyuan City), were included. Additionally, 100-150 middle-aged employees aged 40-59 from Chang Gung Hospital, Formosa Plastics Group, and Chang Gung University were also included.
Who may be able to join
- Willing to sign a written participant consent form.
- Males or females aged 40 or above who have participated in the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging" master planner, or the "Integrated Systematic Medical Information to Explore Solutions for Healthy Aging" project (not subject to exclusion criteria).
- Males or females aged 40-59 who have participated in health checkups for employees of Chang Gung Memorial Hospital, Formosa Plastics Group, or Chang Gung University.
- Those with a medical record of more than one year at Chang Gung Memorial Hospital.
- Those who have resided in Taiwan for more than 180 days in the past year.
Who cannot join
- Individuals with severe organ abnormalities, such as: heart failure (NYHA Fc ≥ III), chronic obstructive pulmonary disease (hospitalization/emergency room visit or medication adjustment within the past month due to disease worsening), decompensated cirrhosis, hemodialysis, or currently undergoing cancer treatment.
- Individuals with a history of severe autoimmune diseases.
- Individuals with a preliminary cognitive and mental assessment score of <26 on the Mini-Mental State Examination (MMSE) or ≥5 on the Generalized Depression Scale (GDS).
- Individuals (who agree to undergo brain MRI) who are deemed unsuitable for MRI after evaluation (e.g., those with pacemakers, cochlear implants, or spatial phobia).
- Individuals who have taken antibiotics within the past month.
- Individuals whose hearing, vision, or cognitive impairments affect communication.
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- Individuals unable to stand or walk (with a walking aid) or with unsteady gait when walking.
- Those who have undergone follow-up outpatient assessments that may affect cognitive function, including but not limited to stroke, Parkinson's syndrome, Parkinson's dementia, epilepsy, brain tumor, or a history of mental illness such as schizophrenia, severe depression, bipolar disorder, alcohol or drug abuse, or a history of loss of consciousness due to severe head trauma.
- Those currently diagnosed with depression and undergoing treatment.
- Those with a past medical history confirming dementia, depression, etc..
- Those deemed unsuitable by a physician.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Chang Gung Memorial Hospital
Taipei, 105
JI-TSENG FANG, Professor, +886-3-3281200, fangjits@cgmh.org.tw
- Recruiting
Taoyuan Chang Gung Memorial Hospital
Taoyuan, 333
JI-TSENG FANG, Professor, +886-3-3281200, fangjits@cgmh.org.tw
About this study
This project aims to build up the comprehensive health database of geriatric medicine for middle-aged and elderly people in Taiwan.
Read the detailed description
This project aims to establish a comprehensive local health database for adults aged 40 and above by integrating clinical data, functional assessments, genomics, metabolomics, and gut microbiome profiles.
The project focuses on validating metabolomic and genetic biomarkers associated with sarcopenia and developing predictive models for early risk identification. Longitudinal multi-omics analyses will be conducted using blood, urine, and fecal samples to explore metabolic dynamics and their links to aging-related conditions. In parallel, the study examines brain health and psychosocial factors, including sleep, resilience, apathy, and loneliness, to better understand their roles in cognitive function and healthy aging.
Through the integration of large-scale health data and advanced analytical approaches, this project aims to support early detection, personalized intervention strategies, and the development of precision healthy aging models.
- 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 40 years old
Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging
Measured: one hour
Secondary outcomes (16)
The actigraphy of local Taiwanese aged over 40 years old
Measure the circadian rhythm (unit in minute) by Actiwatch
Measured: two weeks
The sleep quality questionnaire of local Taiwanese aged over 40 years old
Measure the sleep quality (unit in score) by Pittsburgh Sleep Quality Index (PSQI, Score range: 0 ~ 21, higher is worse)
Measured: one day
The gut microbiota of local Taiwanese aged over 40 years old
Fecal samples were analyzed using 16s full length rRNA gene sequencing to characterize the composition and diversity of the gut microbiota
Measured: one day
The metabolism of local Taiwanese aged over 40 years old
Nuclear Magnetic Resonance (NMR) spectroscopy was employed to perform metabolic profiling of blood samples, with metabolite concentrations quantified in mg/dL, respectively
Measured: one day
The metabolism of local Taiwanese aged over 40 years old
Nuclear Magnetic Resonance (NMR) spectroscopy was employed to perform metabolic profiling of urine samples, with metabolite concentrations quantified in mM, respectively
Measured: one day
The sleep quality questionnaire of local Taiwanese aged over 40 years old
Measure the sleep quality (unit in score) by Stop-Bang Questionnaire (Score range: 0 ~ 8, higher is worse)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Mini-Mental State Examination Score (MMSE, Score range: 0 ~ 30, higher is better)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Geriatric Depression Scale (GDS, Score range: 0 ~ 15, higher is worse)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Short Physical Performance Battery Score (SPPB, Score range: 0 ~ 12, higher is better)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Clinical Frailty Scale (CFS, Score range: 1 ~ 9, higher is worse)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Apathy Evaluation Scale (AES, Score range: 18 ~ 72, higher is worse)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Connor-Davidson Resilience Scale (CD-RISC2, Score range: 0 ~ 8, higher is better)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by UCLA Loneliness Scale (UCLA, Score range: 20 ~ 80, higher is worse)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB, Score range: 0 ~ 100, higher is better)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Hamilton Anxiety Rating Scale (HAM-A, Score range: 0 ~ 56, higher is worse)
Measured: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Measure the mental/neurocognitive condition (unit in score) by Hamilton Depression Rating Scale (HAM-D, Score range: 0 ~ 56, higher is worse)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University
- Responsible party
- Principal investigator, JI-TSENG FANG, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414680
- Sponsor's protocol ID
- 202501674B0A3
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Systematic Data of Medicine to Explore the Solution for Healthy Aging (ISDHA) Phase 4
- ClinicalTrials.gov ID
- NCT07414680
- Acronym / sponsor ID
- 202501674B0A3
- Conditions
- Sleep Disturbance, Cognitive Change, Aging
- Keywords
- dementia, depression, brain structure, system biology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Feb 2026 (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 health database of geriatric medicine for middle-aged and elderly people in Taiwan.
Detailed description
This project aims to establish a comprehensive local health database for adults aged 40 and above by integrating clinical data, functional assessments, genomics, metabolomics, and gut microbiome profiles.
The project focuses on validating metabolomic and genetic biomarkers associated with sarcopenia and developing predictive models for early risk identification. Longitudinal multi-omics analyses will be conducted using blood, urine, and fecal samples to explore metabolic dynamics and their links to aging-related conditions. In parallel, the study examines brain health and psychosocial factors, including sleep, resilience, apathy, and loneliness, to better understand their roles in cognitive function and healthy aging.
Through the integration of large-scale health data and advanced analytical approaches, this project aims to support early detection, personalized intervention strategies, and the development of precision healthy aging models.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- By collecting data from participants in the "Integrating Systemic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrating Systemic Geriatric Medical Information to Explore Solutions for Healthy Aging" main project, and the "Integrating Systemic Medical Information to Explore Solutions for Healthy Aging" project, approximately 100 individuals aged 60 and above, residing in Songshan District of Taipei City, Chang Gung Health and Wellness Village, and Senior Citizens' Health Activity Centers (Shuanglian, New Taipei City; Delai, Taoyuan City), were included. Additionally, 100-150 middle-aged employees aged 40-59 from Chang Gung Hospital, Formosa Plastics Group, and Chang Gung University were also included.
Key inclusion criteria (5 listed)
- Willing to sign a written participant consent form.
- Males or females aged 40 or above who have participated in the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging" master planner, or the "Integrated Systematic Medical Information to Explore Solutions for Healthy Aging" project (not subject to exclusion criteria).
- Males or females aged 40-59 who have participated in health checkups for employees of Chang Gung Memorial Hospital, Formosa Plastics Group, or Chang Gung University.
- Those with a medical record of more than one year at Chang Gung Memorial Hospital.
- Those who have resided in Taiwan for more than 180 days in the past year.
Key exclusion criteria (11 listed)
- Individuals with severe organ abnormalities, such as: heart failure (NYHA Fc ≥ III), chronic obstructive pulmonary disease (hospitalization/emergency room visit or medication adjustment within the past month due to disease worsening), decompensated cirrhosis, hemodialysis, or currently undergoing cancer treatment.
- Individuals with a history of severe autoimmune diseases.
- Individuals with a preliminary cognitive and mental assessment score of <26 on the Mini-Mental State Examination (MMSE) or ≥5 on the Generalized Depression Scale (GDS).
- Individuals (who agree to undergo brain MRI) who are deemed unsuitable for MRI after evaluation (e.g., those with pacemakers, cochlear implants, or spatial phobia).
- Individuals who have taken antibiotics within the past month.
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 40 years old
Time frame: one hour
Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging
16 secondary outcomes
The actigraphy of local Taiwanese aged over 40 years old
Time frame: two weeks
The sleep quality questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The gut microbiota of local Taiwanese aged over 40 years old
Time frame: one day
The metabolism of local Taiwanese aged over 40 years old
Time frame: one day
The metabolism of local Taiwanese aged over 40 years old
Time frame: one day
The sleep quality questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old
Time frame: one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- 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.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JI-TSENG FANG, Professor (+886-3-3281200, 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 40 years old (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.