NCT06490783

Cyber-Human Systems for Personalized Well-being and Health

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2026-05-31
• First posted: 2024-07-08
• Last updated: 2025-05-01

Locations

1 site across 1 country: Italy