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NCT05696496
Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring"
Conditions: Sleep Disorder
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: University Hospital, Clermont-Ferrand
Location: France
Summary
If the video-polysomnographic (vPSG) recording in the laboratory remains the reference examination in Sleep Medicine Centers for the diagnosis of sleep pathologies, the high prevalence of sleep disorders in the general population and the growing demand for exploration and management may require the use of alternative techniques such as new sleep recording or analysis devices.
In collaboration with the Creative Mechatronics Company (Issoire) and the Ennery Confection Company (Le Puy en Velay), we have developed a "portable" sleep detection prototype called Easy Sleep Monitoring (ESM) which consists of an "intelligent" duvet equipped with a series of sensors capable of detecting movements and, through this, estimating sleep duration and quantifying motor phenomena during sleep.
Indeed, it is a duvet which has in its thickness a grid of 35 electronic cards, equipped with an actimetric sensor and a temperature sensor.
The distribution of the sensors makes it possible to detect the motor activity of the sleeper on all the body regions by considerably increasing the sensitivity and specificity compared to actimetry at the wrist.The advantage of this duvet compared to other "wearable" devices is represented by its ease of use, being less restrictive, having a reduced implementation time and not requiring the user's collaboration.
For example, it could be used for sleep monitoring in the elderly and/or in a situation of hypomobility in the context of Residential establishment for dependent elderly people or hospitals.
At home, it could be a sleep monitoring tool, such as monitoring treatment for insomnia, medicinal or not, or to monitor motor activity during sleep, as in the monitoring of nocturnal akinesia in parkinsonian patients.The main objective of this study is to evaluate the concordance of sleep data obtained with the ESM duvet with those obtained by video-polysomnography (vPSG).
Indeed, the vPSG is the gold standard examination in the study of sleep, the only one capable of exactly defining the different stages of sleep and precisely quantifying sleep disorders.
Eligibility Criteria
Inclusion Criteria:For Sleep Disorder Group (TS+):Men or women, aged 18 to 85With a suspected sleep disorder (sleep apnea, restless legs syndrome RLS, syndrome of periodic leg movements during MPJS sleep, REM sleep behavior disorder, Parkinson's disease, Narcolepsy, etc.), requiring a confirmation of the diagnosis in vPSG.Cooperation and understanding to strictly comply with the conditions set out in the protocol - Acceptance of the protocol and signing of a written consentAffiliation to the social security systemFor Control Group (TS- ):Men or women, aged 18 to 85Having no sleep disorder: the Pittsburgh PSQI sleep quality index (Buysse et al., 1989) must be <5.Cooperation and understanding to strictly comply with the conditions set out in the protocol - Acceptance of the protocol and signing of a written consentAffiliation to the social security systemExclusion Criteria:For Group TS+ and TS-:Patients under guardianship or curatorship or safeguard of justicePregnant or breastfeeding women (given the low risk incurred, the verification will be done on simple declaration of the patient)Patients with active implantsduring a period of exclusion from another study,refusing to participate in the study
Source: ClinicalTrials.gov (NCT05696496). StuddyBuddy aggregates publicly available trial information.