Abstract
BACKGROUND: Sarcopenia, altered bone and systemic metabolism, physical frailty and cognitive decline are age-dependent and interrelated phenomena. Sleep disorders which are erroneously considered as part of the aging process might be the unifying underlying mechanism of accelerated aging. It is well-known that impaired sleep health could predict neurodegeneration and functional decline. However, in current clinical practice, sleep disorders are not routinely screened and only a minority of cases require second-tier specialist techniques. The delay of their assessment, without a comprehensive evaluation, results in higher healthcare costs. The aim of SOMNUS-DARE project is to detect, in a translational manner, the role of sleep disorders in the genesis of physical frailty, sarcopenia, mild cognitive impairment, and to measure their contribution to the progression of these phenomena towards mobility-disability and dementia. METHODS: SOMNUS-DARE project will evaluate a sample of 300 community-dwelling healthy active and physically frail sarcopenic subjects, aged 65 years or older, free of cognitive impairment and self-sufficient in basic activities of daily living. The effect of sleep disorders on physical, cognitive and cardiovascular function, systemic, bone and muscle metabolism and body composition will be prospectively assessed by performing: comprehensive geriatric assessment; sleep analysis and environmental monitoring; brain MRI, amyloid positron emission tomography; bone densitometry; radiofrequency echographic multi spectrometry; muscle ultrasound; bioimpedance analysis; cardiac ultrasound; dynamic blood pressure monitoring; blood and saliva measurements. DISCUSSION: The project will make it possible to analyse an extremely relevant public health problem which is still underestimated in the current clinical practice. The combination of traditional diagnostics and innovative digital health techniques, will allow a translational and multidimensional analysis of sleep disorders and to weigh their impact on physical and cognitive decline and quality-of-life trajectories. The expected results will highlight the importance of sleep as a fundamental determinant of health and will contribute to the activation of clinical diagnostic and therapeutic pathways in older individuals where the tailored approach might contribute to substantial benefit. TRIAL REGISTRATION: Clinical Trial Number: NCT06944600; Clinical Trial Registry: ClinicalTrials.gov; Registration Date: April 17th, 2025.