Cyber-Human Systems for Personalized Well-being and Health

NCT ID: NCT06490783

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-05-31

Brief 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 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.

Conditions

Geriatric Health Services; Health Services for the Elderly

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Noninvasive wearable devices (smartwatch and heart rate monitor band)

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Tartarisco

Head of Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gennaro Tartarisco

Role: PRINCIPAL_INVESTIGATOR

Istituto per la Ricerca e l'Innovazione Biomedica

Locations

Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gennaro Tartarisco

Role: CONTACT

gennaro.tartarisco@irib.cnr.it

+393283377046

Maria Valeria Maiorana

Role: CONTACT

mariavaleria.maiorana@irib.cnr.it

Facility Contacts

Serena Iacono Isidoro

Role: primary

serena.iaconoisidoro@irib.cnr.it

References

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.

Reference Type: BACKGROUND

PMID: 35798934 (View on PubMed)

Jan et al.

Reference Type: BACKGROUND

Panicker et al.

Reference Type: BACKGROUND

Other Identifiers

CNR-IRIB-PRO-2024-009

Identifier Type: -

Identifier Source: org_study_id