Chronic DiseaseNCT07541547
Adult Disease Risk Prediction Using Wearables, Hearing, and Health Data
An observational study of Chronic Disease and Risk Assessment, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
This prospective cohort study aims to develop and validate a personalized disease risk prediction model for adults by integrating multiple sources of health data. The study will recruit community-dwelling adults aged 18 years and older in Taiwan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Risk Assessment
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jan 2026to Jan 2029
- How long will I take part?
- 2 Weeks
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling adults aged 18 years and older in Taiwan will be recruited from community settings, including community care stations, public health centers, activity centers, lifelong learning centers for older adults, and collaborating local organizations. Public recruitment may also be conducted through online platforms and social media. Recruitment will be carried out across multiple geographic regions in Taiwan to include participants from both urban and rural communities.
Who may be able to join
- Adults aged 18 years and older
- Living in the community in Taiwan
- Able to understand the study procedures and provide written informed consent
- Able and willing to complete the study questionnaire, hearing assessment, and wearable device monitoring procedures
- Has access to a smartphone and is able to install and use the study-related application, with assistance from study staff if needed
Who cannot join
- Diagnosis of dementia
- Too frail or has other health conditions that make participation in the study procedures not feasible
- Bilateral deafness without use of any hearing assistive device
- Does not have a smartphone or is unable to use a smartphone application required for the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Health Research Institutes
Zhunan, Miaoli, 350
Ren-Hua Chung, PhD, 886-37206166 ext. 36105, rchung@nhri.edu.tw
About this study
Official title: A Study to Build a Disease Risk Prediction Model for Adults by Integrating Data From Wearable Devices, Hearing Tests, and Multiple Health Databases
This prospective cohort study aims to develop and validate a personalized disease risk prediction model for adults by integrating multiple sources of health data. The study will recruit community-dwelling adults aged 18 years and older in Taiwan. After providing informed consent, participants will complete a structured questionnaire, undergo pure tone hearing testing, and wear a smartwatch for 2 weeks to collect continuous physiological data, including heart rate and physical activity. With participant authorization, the study will also collect data from personal health records and national health insurance databases to allow longer-term follow-up of health outcomes.
The main goals of the study are to examine the relationships among hearing, lifestyle factors, and wearable device data; to identify combinations of risk factors associated with progression from health to subclinical or chronic disease states; and to develop analytical methods for integrating heterogeneous health data from questionnaires, physiological monitoring, hearing tests, and medical databases. Machine learning methods will be used to identify important predictors and build risk prediction models.
The study hypothesis is that combining hearing measures, lifestyle information, wearable physiological data, and longitudinal medical record data will improve the ability to identify individuals at higher risk of future disease compared with using a single source of information alone. The long-term objective is to support early risk identification, personalized health management, and prevention strategies in community adults.
Read the detailed description
This study is a prospective cohort study designed to integrate multimodal health data for the development and validation of personalized disease risk prediction models in community-dwelling adults in Taiwan. The study focuses on combining actively collected research data, continuous wearable device data, hearing assessment results, and longitudinal health records to better understand the transition from health to subclinical states and chronic disease.
Participants aged 18 years and older will be recruited from community settings. After informed consent is obtained, study procedures will include a structured questionnaire, pure tone audiometry, and 2 weeks of smartwatch monitoring. The questionnaire will collect demographic characteristics, personal and family disease history, and lifestyle factors such as exercise, sleep, smoking, and alcohol use. Hearing function will be assessed using pure tone audiometry. Continuous physiological data collected from the wearable device will include heart rate and physical activity, such as step counts. Research staff will assist participants with device setup, application installation, and instructions for use to improve data completeness and consistency.
With participant authorization, the study will also obtain personal health record data and link study data with national health insurance databases to support longitudinal follow-up and ascertainment of disease outcomes. These linked data sources may include outpatient, inpatient, pharmacy, insurance enrollment, catastrophic illness, death registry, cancer registry, and adult preventive health examination records. The integration of these heterogeneous data sources is intended to provide a more complete picture of individual health trajectories and disease progression than can be achieved with any single data source alone.
The scientific objectives of the study are to:
- evaluate the associations among hearing status, lifestyle factors, and continuous wearable-derived physiological measures;
- identify combinations of key predictors associated with progression from health to subclinical or chronic disease states;
- establish an analytical framework for integrating heterogeneous data from questionnaires, hearing tests, wearable monitoring, and medical databases; and
- develop and validate high-accuracy personalized disease risk prediction models using statistical and machine learning methods.
Data processing will include data cleaning, handling of missing values, outlier checking, standardization, and cross-source data integration. Statistical analyses will include correlation and regression approaches to examine relationships among hearing, lifestyle, and wearable variables. Machine learning methods, including feature selection and supervised learning algorithms such as random forests and gradient boosting methods, will be used to identify important predictors and construct risk prediction models. Model performance will be evaluated using measures such as area under the receiver operating characteristic curve and accuracy. Internal and, where available, external validation strategies will be used to assess robustness and generalizability.
The central hypothesis of the study is that integrating hearing measures, lifestyle information, wearable physiological data, and longitudinal medical record data will improve disease risk prediction compared with models based on a single type of data alone. The long-term goal is to support early identification of high-risk individuals, facilitate personalized health management, and provide evidence for preventive health strategies in adult populations.
A strong emphasis will be placed on data privacy and confidentiality. All study data will be coded using unique study identifiers. The linkage file connecting study identifiers to personal identifiers will be stored separately with restricted access and encryption. After data collection, cleaning, and linkage procedures are completed and verified, the linkage file will be permanently destroyed so that subsequent analyses are conducted on de-identified data only. Any reports or publications resulting from the study will present aggregated findings without personally identifiable information.
- Conditions
- Chronic Disease, Risk Assessment
- Keywords
- Wearable Devices, Risk Assessment, Chronic Disease, Disease Prediction, Machine Learning, Cohort Studies, Physiological Monitoring, Personal Health Records, Health Insurance Claims
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community-Dwelling Adults | Adults aged 18 years and older recruited from community settings in Taiwan. Participants will complete a structured questionnaire, undergo hearing assessment, wear a smartwatch for 2 weeks, and authorize collection of personal health records and linked national health insurance data for health outcome follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Personalized Disease Risk Prediction Models
Model performance will be evaluated for personalized disease risk prediction models developed using integrated questionnaire, hearing, wearable device, personal health record, and national health insurance data. Performance metrics will include area under the receiver operating characteristic curve (AUC-ROC), accuracy, and related validation measures in training and test datasets.
Measured: At the completion of data collection and model validation, including baseline assessment and 2-week wearable monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start9 Jan 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541547
- Sponsor's protocol ID
- EC1140910
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study involves sensitive personal health information, including questionnaire data, hearing assessment data, wearable device data, personal health records, and linked national health insurance database records. Although study data will be de-identified for analysis, the protocol includes strict privacy protection and data security procedures, and no plan for external sharing of individual participant data has been established.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Build a Disease Risk Prediction Model for Adults by Integrating Data From Wearable Devices, Hearing Tests, and Multiple Health Databases
- ClinicalTrials.gov ID
- NCT07541547
- Acronym / sponsor ID
- EC1140910
- Conditions
- Chronic Disease, Risk Assessment
- Keywords
- Wearable Devices, Risk Assessment, Chronic Disease, Disease Prediction, Machine Learning, Cohort Studies, Physiological Monitoring, Personal Health Records
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 21 Apr 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 prospective cohort study aims to develop and validate a personalized disease risk prediction model for adults by integrating multiple sources of health data. The study will recruit community-dwelling adults aged 18 years and older in Taiwan. After providing informed consent, participants will complete a structured questionnaire, undergo pure tone hearing testing, and wear a smartwatch for 2 weeks to collect continuous physiological data, including heart rate and physical activity. With participant authorization, the study will also collect data from personal health records and national health insurance databases to allow longer-term follow-up of health outcomes.
The main goals of the study are to examine the relationships among hearing, lifestyle factors, and wearable device data; to identify combinations of risk factors associated with progression from health to subclinical or chronic disease states; and to develop analytical methods for integrating heterogeneous health data from questionnaires, physiological monitoring, hearing tests, and medical databases. Machine learning methods will be used to identify important predictors and build risk prediction models.
The study hypothesis is that combining hearing measures, lifestyle information, wearable physiological data, and longitudinal medical record data will improve the ability to identify individuals at higher risk of future disease compared with using a single source of information alone. The long-term objective is to support early risk identification, personalized health management, and prevention strategies in community adults.
Detailed description
This study is a prospective cohort study designed to integrate multimodal health data for the development and validation of personalized disease risk prediction models in community-dwelling adults in Taiwan. The study focuses on combining actively collected research data, continuous wearable device data, hearing assessment results, and longitudinal health records to better understand the transition from health to subclinical states and chronic disease.
Participants aged 18 years and older will be recruited from community settings. After informed consent is obtained, study procedures will include a structured questionnaire, pure tone audiometry, and 2 weeks of smartwatch monitoring. The questionnaire will collect demographic characteristics, personal and family disease history, and lifestyle factors such as exercise, sleep, smoking, and alcohol use. Hearing function will be assessed using pure tone audiometry. Continuous physiological data collected from the wearable device will include heart rate and physical activity, such as step counts. Research staff will assist participants with device setup, application installation, and instructions for use to improve data completeness and consistency.
With participant authorization, the study will also obtain personal health record data and link study data with national health insurance databases to support longitudinal follow-up and ascertainment of disease outcomes. These linked data sources may include outpatient, inpatient, pharmacy, insurance enrollment, catastrophic illness, death registry, cancer registry, and adult preventive health examination records. The integration of these heterogeneous data sources is intended to provide a more complete picture of individual health trajectories and disease progression than can be achieved with any single data source alone.
The scientific objectives of the study are to:
- evaluate the associations among hearing status, lifestyle factors, and continuous wearable-derived physiological measures;
- identify combinations of key predictors associated with progression from health to subclinical or chronic disease states;
- establish an analytical framework for integrating heterogeneous data from questionnaires, hearing tests, wearable monitoring, and medical databases; and
- develop and validate high-accuracy personalized disease risk prediction models using statistical and machine learning methods.
Data processing will include data cleaning, handling of missing values, outlier checking, standardization, and cross-source data integration. Statistical analyses will include correlation and regression approaches to examine relationships among hearing, lifestyle, and wearable variables. Machine learning methods, including feature selection and supervised learning algorithms such as random forests and gradient boosting methods, will be used to identify important predictors and construct risk prediction models. Model performance will be evaluated using measures such as area under the receiver operating characteristic curve and accuracy. Internal and, where available, external validation strategies will be used to assess robustness and generalizability.
The central hypothesis of the study is that integrating hearing measures, lifestyle information, wearable physiological data, and longitudinal medical record data will improve disease risk prediction compared with models based on a single type of data alone. The long-term goal is to support early identification of high-risk individuals, facilitate personalized health management, and provide evidence for preventive health strategies in adult populations.
A strong emphasis will be placed on data privacy and confidentiality. All study data will be coded using unique study identifiers. The linkage file connecting study identifiers to personal identifiers will be stored separately with restricted access and encryption. After data collection, cleaning, and linkage procedures are completed and verified, the linkage file will be permanently destroyed so that subsequent analyses are conducted on de-identified data only. Any reports or publications resulting from the study will present aggregated findings without personally identifiable information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-Dwelling Adults | – | –Adults aged 18 years and older recruited from community settings in Taiwan. Participants will complete a structured questionnaire, undergo hearing assessment, wear a smartwatch for 2 weeks, and authorize collection of personal health records and linked national health insurance data for health outcome follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling adults aged 18 years and older in Taiwan will be recruited from community settings, including community care stations, public health centers, activity centers, lifelong learning centers for older adults, and collaborating local organizations. Public recruitment may also be conducted through online platforms and social media. Recruitment will be carried out across multiple geographic regions in Taiwan to include participants from both urban and rural communities.
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Living in the community in Taiwan
- Able to understand the study procedures and provide written informed consent
- Able and willing to complete the study questionnaire, hearing assessment, and wearable device monitoring procedures
- Has access to a smartphone and is able to install and use the study-related application, with assistance from study staff if needed
Key exclusion criteria (4 listed)
- Diagnosis of dementia
- Too frail or has other health conditions that make participation in the study procedures not feasible
- Bilateral deafness without use of any hearing assistive device
- Does not have a smartphone or is unable to use a smartphone application required for the study procedures
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
Performance of Personalized Disease Risk Prediction Models
Time frame: At the completion of data collection and model validation, including baseline assessment and 2-week wearable monitoring
Model performance will be evaluated for personalized disease risk prediction models developed using integrated questionnaire, hearing, wearable device, personal health record, and national health insurance data. Performance metrics will include area under the receiver operating characteristic curve (AUC-ROC), accuracy, and related validation measures in training and test datasets.
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 21 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study involves sensitive personal health information, including questionnaire data, hearing assessment data, wearable device data, personal health records, and linked national health insurance database records. Although study data will be de-identified for analysis, the protocol includes strict privacy protection and data security procedures, and no plan for external sharing of individual participant data has been established.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Risk Assessment, run by National Health Research Institutes, Taiwan at 1 site 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 4 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ren-Hua Chung, PhD (886-37206166 ext. 36105, rchung@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Personalized Disease Risk Prediction Models (time frame: At the completion of data collection and model validation, including baseline assessment and 2-week wearable monitoring). 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 21 Apr 2026.