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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • National Health Research Institutes

    Zhunan, Miaoli, 350

    Ren-Hua Chung, PhD, 886-37206166 ext. 36105, rchung@nhri.edu.tw

    Recruiting

Other trials in Taiwan

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:

  1. evaluate the associations among hearing status, lifestyle factors, and continuous wearable-derived physiological measures;
  2. identify combinations of key predictors associated with progression from health to subclinical or chronic disease states;
  3. establish an analytical framework for integrating heterogeneous data from questionnaires, hearing tests, wearable monitoring, and medical databases; and
  4. 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.

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 groups in NCT07541547
Study groupRoleWhat they receive
Community-Dwelling AdultsAdults 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.

  1. 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.

  1. First posted21 Apr 2026
  2. Study start9 Jan 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

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
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.

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.

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