Geriatric Health ServicesRESILIENTNCT06490783
Cyber-Human Systems for Personalized Well-being and Health
An observational study of Geriatric Health Services and Health Services for the Elderly, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Health Services, Health Services for the Elderly
- What is being tested?
- Noninvasive wearable devices (smartwatch and heart rate monitor band)
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 31 May 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- healthy male and female aged 60 years and older
- signing of informed consent
Who cannot join
- chronic diseases
- cardiovascular disease
- presence of dementia and/or depression
- presence of confirmed paranoid or psychotic symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Valeria Maiorana contact
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy
Messina, 98164
Serena Iacono Isidoro, serena.iaconoisidoro@irib.cnr.it
Gennaro Tartarisco
About this study
Official title: 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.
- Being tested
- Noninvasive wearable devices (smartwatch and heart rate monitor band)
- Keywords
- elderly, wellbeing, Artificial Intelligence, quality of life, AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive wearable devices (smartwatch and heart rate monitor band)Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Noninvasive wearable devices (smartwatch and heart rate monitor band) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate(HR)
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).
Measured: Through study completion, an average of 1 year
Heart rate variability (HRV)
The chest strap Polar H10 measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms).
Measured: Through study completion, an average of 1 year
Facial emotion recognition
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.
Measured: Through study completion, an average of 1 year
Steps taken
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.
Measured: Through study completion, an average of 1 year
Distance traveled
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).
Measured: Through study completion, an average of 1 year
Calories burned
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Geriatric Health ServicesStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Tartarisco, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Gennaro Tartarisco, Principal investigator, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490783
- Sponsor's protocol ID
- CNR-IRIB-PRO-2024-009
- Acronym
- RESILIENT
- Status last verified
- Apr 2025
- First submitted
- 17 Jun 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abd-Alrazaq A, Alhuwail D, Schneider J, Toro CT, Ahmed A, Alzubaidi M, Alajlani M, Househ M. The performance of artificial intelligence-driven technologies in diagnosing mental disorders: an umbrella review. NPJ Digit Med. 2022 Jul 7;5(1):87. doi: 10.1038/s41746-022-00631-8.
PubMed 35798934Jan et al.
Panicker et al.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CybeR-human systEms for perSonalIzed mentaL and physIcal wEll-beiNg and Health
- ClinicalTrials.gov ID
- NCT06490783
- Acronym / sponsor ID
- RESILIENT / CNR-IRIB-PRO-2024-009
- Keywords
- elderly, wellbeing, Artificial Intelligence, quality of life, AI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Jul 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy elderly | – | Other: Noninvasive wearable devices (smartwatch and heart rate monitor band)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- healthy male and female aged 60 years and older
- signing of informed consent
Key exclusion criteria (4 listed)
- chronic diseases
- cardiovascular disease
- presence of dementia and/or depression
- presence of confirmed paranoid or psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | healthy elderly |
Primary outcome
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).
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).
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.
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.
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).
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.
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 1 May 2025.
- Background: PubMed 35798934Abd-Alrazaq A, Alhuwail D, Schneider J, Toro CT, Ahmed A, Alzubaidi M, Alajlani M, Househ M. The performance of artificial intelligence-driven technologies in diagnosing mental disorders: an umbrella review. NPJ Digit Med. 2022 Jul 7;5(1):87. doi: 10.1038/s41746-022-00631-8.
- BackgroundJan et al.
- BackgroundPanicker et al.
- 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.
Maria Valeria Maiorana contact
Gennaro Tartarisco principal investigator
Istituto per la Ricerca e l'Innovazione Biomedica
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 Geriatric Health Services and Health Services for the Elderly, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 2 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 1 May 2025. 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 Italy. 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 Gennaro Tartarisco (+393283377046, gennaro.tartarisco@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate(HR) (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490783, which also lists 3 linked publications.
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 1 May 2025.