NCT07541547

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

Study Start

First participant enrolled

January 9, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Wearable DevicesRisk AssessmentChronic DiseaseDisease PredictionMachine LearningCohort StudiesPhysiological MonitoringPersonal Health RecordsHealth Insurance Claims

Outcome Measures

Primary Outcomes (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.

    At the completion of data collection and model validation, including baseline assessment and 2-week wearable monitoring

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Research Institutes

Zhunan, Miaoli, 350, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ren-Hua Chung, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 21, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations