Cyber-Human Systems for Personalized Well-being and Health (RESILIENT)

April 29, 2025 updated by: Gennaro Tartarisco, Istituto per la Ricerca e l'Innovazione Biomedica

CybeR-human systEms for perSonalIzed mentaL and physIcal wEll-beiNg and Health

The purpose of the present study is to evaluate the effectiveness of using multi-parameter monitoring devices in the elderly to improve their quality of life not already understood as the absence of disease but in a logic that is intrinsically linked to the body-mind relationship, which is increasingly significant as biological age advances. The study will be conducted on a sample of volunteer elderly subjects who will wear devices capable of constantly monitoring vital parameters such as heart rate, physical activity, sleep quality, stress levels and higher level activities, linked sensory and cognitive aspects ecologically integrated with the elderly person's living environment, in the sense of an evaluative and qualitative focus on relationships within the person's area of action/interaction, possibly supported and stimulated by individualized and easily usable activities. The signals interpreted and returned by the technology to the elderly person who uses it can also act as a reassuring self-assessment of even normal body states, sometimes experienced as threatening and anxiogenic, thus stressful. The collection and management of these data may serve as a reference to the recognition of distress signals and complex experiences (e.g., depressive) that normally have significant effects on mental health, understood as intrinsically linked to the health of the body.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy, 98164
        • Recruiting
        • Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy
        • Sub-Investigator:
          • Roberta Bruschetta
        • Sub-Investigator:
          • Simona Campisi
        • Contact:
        • Principal Investigator:
          • Gennaro Tartarisco
        • Sub-Investigator:
          • Serena Iacono Isidoro
        • Sub-Investigator:
          • Gaspare Cusimano
        • Sub-Investigator:
          • Rosanna Turrisi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The elderly population plays a significant role in society, influencing social, economic, and cultural aspects. Intellectual stimulation and social interactions are crucial for keeping their minds active and preventing isolation, decline and depression. Physical activity can help to maintain strength and balance, preventing motor decline and reducing the risk of falls and injuries. Issues such as loss of intrinsic abilities, exposure to adversity, and functional deterioration can cause psychological distress. Common concerns among the elderly include health changes, loss of loved ones, income reduction, and a diminished sense of purpose after retirement. A proactive approach to health management and a strong support system can significantly enhance the overall well-being of the elderly.

Description

Inclusion Criteria:

  • healthy male and female aged 60 years and older
  • signing of informed consent

Exclusion Criteria:

  • chronic diseases
  • cardiovascular disease
  • presence of dementia and/or depression
  • presence of confirmed paranoid or psychotic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy elderly
The sample consists of healthy elderly volunteers who will wear noninvasive wearable devices (smartwatch and heart rate monitor band) to monitor physiological parameters and emotional states related to anxiety and stress.
Other: Noninvasive wearable devices (smartwatch and heart rate monitor band)

Each enrolled subject will be equipped with noninvasive wearable devices (smartwatch and heart rate monitor band) to monitor physiological parameters and emotional states related to anxiety and stress. Each subject will be required to wear the smartwatch on his or her wrist for the duration of the study, about 3-6 months; while the heart rate monitor band will be worn for about 10 minutes a day. At the same time, a mobile application, RESILIENT, will be developed and implemented to serve as the main interface for self-assessment data entry and for feedback and recommendations.

The psycho-physical condition of each subject will be monitored by the app through customized and contextualized mental exercises based on daily activities. This approach will test the effectiveness of the proposed architecture in reducing unhealthy habits and promoting health and wellness recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate(HR)
Time Frame: Through study completion, an average of 1 year
The chest strap Polar H10 uses an electrocardiogram (ECG) sensor to detect the electrical activity of the heart and calculate heart rate in beats per minute (bpm).
Through study completion, an average of 1 year
Heart rate variability (HRV)
Time Frame: Through study completion, an average of 1 year
The chest strap Polar H10 measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms).
Through study completion, an average of 1 year
Facial emotion recognition
Time Frame: Through study completion, an average of 1 year

The smartphone's camera records facial expressions in order to evaluate and quantify human emotions.

The Artificial Intelligence (AI) algorithms, recognizing the human face, identify important facial features and examine them to categorize different facial emotions. The emotions associated with these facial expressions are then extracted.
Through study completion, an average of 1 year
Steps taken
Time Frame: Through study completion, an average of 1 year
This refers to the total number of times each subject take a step with either foot. It's a basic unit to measure overall activity level. Fitness trackers typically use steps to monitor movement throughout the day.
Through study completion, an average of 1 year
Distance traveled
Time Frame: Through study completion, an average of 1 year
This indicates the actual physical length each subject covered during activity. It's usually measured in miles or kilometers. Distance traveled can be calculated based on the number of steps you take and your stride length (the distance between two consecutive footfalls with the same foot).
Through study completion, an average of 1 year
Calories burned
Time Frame: Through study completion, an average of 1 year
This refers to the amount of energy each subject's body expends during activity. It's measured in calories (kcal). The number of calories burned depends on various factors like weight, height, activity intensity (e.g., walking vs running), and duration. Fitness trackers typically estimate calorie burn based on steps taken, distance traveled, and personal information.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Investigators

  • Principal Investigator: Gennaro Tartarisco, Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CNR-IRIB-PRO-2024-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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