An observational study in Aging, Fall Risk Factors and Sleep, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
Aging is a condition characterized by a general decline in physical and cognitive performance, however its effects on various functions are still controversial. These changes lead to an increased risk of injuries, particularly due to falls. According to the World Health Organization (WHO) report, 28-35% of individuals aged over 65 experience a fall each year, and this percentage increases with age. For this reason, preventing falls among the elderly is undeniably one of the most critical public health issues in today's aging society. Nowadays, it is widely demonstrated that the loss of muscle strength and mass, along with decreased balance, significantly increases the risk of falls. However, with aging, numerous other changes occur that contribute to an increased risk of falls, such as a decline in cognitive function, including attention, reaction capabilities and memory, as well as other factors that worsen the quality of life, such as insufficient sleep or nutrition. According to WHO estimates, by 2030, the number of injuries due to falls will double. Therefore, it is of great importance to understand and analyze the factors contributing to falls among older adults in everyday life. For this reason, the principal aim of this study was to evaluate the correlation between the fall index and the Visual Attention, Reaction Time and visual field using the technologies of Virtual Reality (VR). Since aging brigs changes in different aspect, the secondary objectives aim to study the correlation also with i) sleep quantity and quality parameters, ii) risk of malnutrition, and iii) physical condition, muscle conditions and strength in order to have a comprehensive understanding of the factors that most contribute to the risk of falls. In addition to these objectives, the correlation between acute sleep deprivation and the risk of falls will also be analyzed, in order to understand how inadequate sleep quantity can impact injuries in the elderly.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A minimum of 100 subjects aged 60 years or older will be recruited, but recruitment will continue until enough subjects are identified to reach the predetermined number for the second study. The subjects are chosen on the basis of the following inclusion and exclusion criteria
Exclusion Criteria:
30 - second chair stand test
to assess the leg strength and endurance in older adults. Being in a specific sitting position on a chair, the test consists of getting up and sitting down as many times as possible in 30 seconds
Time frame: 10 days ± 3 days after the familiarization day
Virtual reality (VR-Brain Tracker)
Evaluation to assess visual attention through the Multiple Object Tracking paradigm.
Time frame: 10 days ± 3 days after the familiarization day
Strength asessment
Handgrip Test (Kg) Flexors and Extensors of thigh muscles (Kg)
Time frame: 10 days ± 3 days after the familiarization day
Balance test
balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)
Time frame: 10 days ± 3 days after the familiarization day
Sleep assessment
Objective assessment of sleep quantity and quality using the MotionWatch 8® (CamTec, USA), and sleep diary.
Time frame: sleep monitoring duration: 10 days ± 3 days after the familiarization day
Sleep Hygene Index
Questionnaire to assess the sleep hygene
Time frame: 10 days ± 3 days after the familiarization day
Body Impedence Assessment
to assess body composition by measuring the resistance of electrical flow through the body. It helps estimate parameters like body fat percentage, muscle mass, and water content. BIA is commonly used in health and fitness settings to monitor changes in body composition, guide nutritional and fitness plans, and assess overall health.
Time frame: T1
Virtual reality (CNS Sprint)
To assess the response time (ms)
Time frame: 10 days ± 3 days after the familiarization day
Virtual reality (Visual efficiency)
To assess the visual field
Time frame: 10 days ± 3 days after the familiarization day
The Pittsburgh Sleep Quality Index
Questionnaire to assess sleep quality
Time frame: 10 days ± 3 days after the familiarization day
Morningness-Eveningness Questionnaire
Questionnaire to assess the chronotype
Time frame: 10 days ± 3 days after the familiarization day
Karolinska Sleepiness Scale
Scale to assess the sleepiness
Time frame: 10 days ± 3 days after the familiarization day
Tiredness Severity Scale
Scale to assess the tiredness
Time frame: 10 days ± 3 days after the familiarization day
SARC-F
A QUESTIONNAIRE FOR SCREENING THE RISK OF SARCOPENIA
Time frame: 10 days ± 3 days after the familiarization day
International Physical Activity Questionnaire
Questionnaire to assess the physical activity
Time frame: 10 days ± 3 days after the familiarization day
BORG-CR10 scale
EFFORT PERCEPTION SCALE
Time frame: 10 days ± 3 days after the familiarization day
Mini Nutritional Assessment
QUESTIONNAIRE TO ASSESS THE RISK OF MALNUTRITION
Time frame: 10 days ± 3 days after the familiarization day
Nutritional diary
Keeping a food diary helps collect accurate data on participants' eating habits for scientific analysis.
Time frame: 10 days ± 3 days after the familiarization day
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio