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NCT Number: NCT05696496

Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring"

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.

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, UMR INSERM 1107

Clermont-Ferrand, France

About this study

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:

Each subject will have 2 visits:

  • First visit (baseline, inclusion visit, 30 minutes) which will include:
  • Information and collection of written consent
  • Recording of demographic and clinical data (age, sex, duration of disease progression, current treatments, medical and surgical history)
  • Pittsburgh PSQI Sleep Quality Index (for TS- group only)
  • Verification of inclusion and non-inclusion criteria.
  • Visit 2 (Month 6) (duration 1 night): The patients/controls will arrive in the evening at the Sleep Laboratory (Functional Exploration Department of the Nervous System of the Clermont-Ferrand University Hospital) to carry out complete vPSG and test the new ESM "intelligent duvet" device.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 <5.
  • 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

Exclusion criteria

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

Treatment and study plan

night recording

Device

The patients/controls will arrive in the evening at the Sleep Laboratory (Functional Exploration Department of the Nervous System of the Clermont-Ferrand University Hospital) to carry out complete vPSG and test the new ESM "intelligent duvet"device. A qualified technician will place the electrodes according to the procedures usually followed at the Sleep Center for vPSG recording. The ESM duvet will be placed on the patient's body as a blanket, instead of the blankets normally provided by the hospital. Patients/controls will be monitored overnight by an infrared video camera.

Primary outcomes

  1. Effective sleep duration (in minutes)

    Time frame: Month 6

    evaluated by vPSG

  2. Effective sleep duration (in minutes)

    Time frame: Month 6

    evaluated by ESM device

Secondary outcomes

  1. Time spent in bed (in minutes)

    Time frame: Month 6

    evaluated by vPSG

  2. Time spent in bed (in minutes)

    Time frame: Month 6

    evaluated by ESM device

  3. Sleep efficiency (Total sleep time/Time spent in bed)

    Time frame: Month 6

    evaluated by vPSG

  4. Sleep efficiency (Total sleep time/Time spent in bed)

    Time frame: Month 6

    evaluated by ESM device

  5. Sleep latency (in minutes)

    Time frame: Month 6

    evaluated by vPSG

  6. Sleep latency (in minutes)

    Time frame: Month 6

    evaluated by ESM device

  7. Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)(in minutes)

    Time frame: Month 6

    evaluated by vPSG

  8. Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep) (in minutes)

    Time frame: Month 6

    evaluated by ESM device

  9. % of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)

    Time frame: Month 6

    evaluated by vPSG

  10. % of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)

    Time frame: Month 6

    evaluated by ESM device

  11. Number of alarm clocks

    Time frame: Month 6

    evaluated by vPSG

  12. Number of alarm clocks

    Time frame: Month 6

    evaluated by ESM device

  13. Number of position changes

    Time frame: Month 6

    evaluated by vPSG

  14. Number of position changes

    Time frame: Month 6

    evaluated by ESM device

  15. Duration of periodic movements of the lower limbs (in minutes)

    Time frame: Month 6

    evaluated by vPSG

  16. Duration of periodic movements of the lower limbs (in minutes)

    Time frame: Month 6

    evaluated by ESM device

  17. Duration of Cheyne-Stokes periodic breathing (in minutes)

    Time frame: Month 6

    evaluated by vPSG

  18. Duration of Cheyne-Stokes periodic breathing (in minutes)

    Time frame: Month 6

    evaluated by ESM device

  19. number of obstructive and central apneas

    Time frame: Month 6

    evaluated by vPSG

  20. number of obstructive and central apneas

    Time frame: Month 6

    evaluated by ESM device

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: ESM

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 25, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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