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临床试验/NCT05696496
NCT05696496进行中(未招募)不适用

Évaluation d'un Dispositif de détection du Sommeil " Easy Sleep Monitoring " (ou " Couette Intelligente ") Par Rapport à la vidéo-polysomnographie, Chez Des Patients Avec Des Troubles du Sommeil et Des Sujets Sains

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
2
主要终点
Effective sleep duration (in minutes)

研究概览

简要总结

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.

详细描述

Type of study : monocentric study, a proof of concept study of a new device for sleep detection "Easy Sleep Monitoring" (ESM). This is a category 4.4 clinical investigation with a non-CE marked medical device used in its indication, without the objective of CE marking or establishing compliance

Number of centers: 1

Patients:

This study will be perdormed in 50 subjects (25 patients with sleep disorders (TS+) + 25 subjects without proven sleep disorders (TS-))

Study performance:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For Sleep Disorder Group (TS+):
  • •Men or women, aged 18 to 85
  • •With 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 consent
  • •Affiliation to the social security system
  • •For Control Group (TS- ):
  • •Men or women, aged 18 to 85
  • •Having no sleep disorder: the Pittsburgh PSQI sleep quality index (Buysse et al., 1989) must be <
  • •Cooperation and understanding to strictly comply with the conditions set out in the protocol - Acceptance of the protocol and signing of a written consent
  • •Affiliation to the social security system

排除标准

  • •For Group TS+ and TS-:
  • •Patients under guardianship or curatorship or safeguard of justice
  • •Pregnant or breastfeeding women (given the low risk incurred, the verification will be done on simple declaration of the patient)
  • •Patients with active implants
  • •during a period of exclusion from another study,
  • •refusing to participate in the study

研究组 & 干预措施

Patients with sleep disorders (TS+)

Experimental

video polysomnography; the new ESM "intelligent duvet" device

干预措施: night recording (Device)

control group without sleep disorder (TS-)

Experimental

video polysomnography; the new ESM "intelligent duvet" device

干预措施: night recording (Device)

结局指标

主要结局

Effective sleep duration (in minutes)

时间窗: Month 6

evaluated by vPSG

次要结局

  • Time spent in bed (in minutes)(Month 6)
  • Sleep efficiency (Total sleep time/Time spent in bed)(Month 6)
  • Sleep latency (in minutes)(Month 6)
  • % of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)(Month 6)
  • Number of alarm clocks(Month 6)
  • Number of position changes(Month 6)
  • Duration of periodic movements of the lower limbs (in minutes)(Month 6)
  • Duration of Cheyne-Stokes periodic breathing (in minutes)(Month 6)
  • number of obstructive and central apneas(Month 6)
  • Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)(in minutes)(Month 6)
  • Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep) (in minutes)(Month 6)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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