Sleep DisorderESMNCT05696496
Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring"
A study testing night recording in people with Sleep Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- night recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2023to 25 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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- ):
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Sleep Disorder
- Being tested
- night recording
- Keywords
- video polysomnography, new sleep detection device
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
night recordingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sleep disorders (TS+) | Experimental | video polysomnography; the new ESM "intelligent duvet" device Receives: Device: night recording |
| control group without sleep disorder (TS-) | Experimental | video polysomnography; the new ESM "intelligent duvet" device Receives: Device: night recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective sleep duration (in minutes)
evaluated by vPSG
Measured: Month 6
Effective sleep duration (in minutes)
evaluated by ESM device
Measured: Month 6
Secondary outcomes (20)
Time spent in bed (in minutes)
evaluated by vPSG
Measured: Month 6
Time spent in bed (in minutes)
evaluated by ESM device
Measured: Month 6
Sleep efficiency (Total sleep time/Time spent in bed)
evaluated by vPSG
Measured: Month 6
Sleep efficiency (Total sleep time/Time spent in bed)
evaluated by ESM device
Measured: Month 6
Sleep latency (in minutes)
evaluated by vPSG
Measured: Month 6
Sleep latency (in minutes)
evaluated by ESM device
Measured: Month 6
Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)(in minutes)
evaluated by vPSG
Measured: Month 6
Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep) (in minutes)
evaluated by ESM device
Measured: Month 6
% of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)
evaluated by vPSG
Measured: Month 6
% of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)
evaluated by ESM device
Measured: Month 6
Number of alarm clocks
evaluated by vPSG
Measured: Month 6
Number of alarm clocks
evaluated by ESM device
Measured: Month 6
Number of position changes
evaluated by vPSG
Measured: Month 6
Number of position changes
evaluated by ESM device
Measured: Month 6
Duration of periodic movements of the lower limbs (in minutes)
evaluated by vPSG
Measured: Month 6
Duration of periodic movements of the lower limbs (in minutes)
evaluated by ESM device
Measured: Month 6
Duration of Cheyne-Stokes periodic breathing (in minutes)
evaluated by vPSG
Measured: Month 6
Duration of Cheyne-Stokes periodic breathing (in minutes)
evaluated by ESM device
Measured: Month 6
number of obstructive and central apneas
evaluated by vPSG
Measured: Month 6
number of obstructive and central apneas
evaluated by ESM device
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start25 Jan 2023
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- the 2 groups (patients with Sleep Disorder Group (TS+) and the control group (TS-)) will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696496
- Sponsor's protocol ID
- RBHP 2022 FANTINI
- Acronym
- ESM
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05696496
- Acronym / sponsor ID
- ESM / RBHP 2022 FANTINI
- Conditions
- Sleep Disorder
- Keywords
- video polysomnography, new sleep detection device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the 2 groups (patients with Sleep Disorder Group (TS+) and the control group (TS-)) will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Patients with sleep disorders (TS+) | Experimental | Device: night recordingvideo polysomnography; the new ESM "intelligent duvet" device |
| control group without sleep disorder (TS-) | Experimental | Device: night recordingvideo polysomnography; the new ESM "intelligent duvet" device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Men or women, aged 18 to 85
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| night recordingThe 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. | Device | Patients with sleep disorders (TS+), control group without sleep disorder (TS-) |
Primary outcome
Effective sleep duration (in minutes)
Time frame: Month 6
evaluated by vPSG
Effective sleep duration (in minutes)
Time frame: Month 6
evaluated by ESM device
20 secondary outcomes
Time spent in bed (in minutes)
Time frame: Month 6
Time spent in bed (in minutes)
Time frame: Month 6
Sleep efficiency (Total sleep time/Time spent in bed)
Time frame: Month 6
Sleep efficiency (Total sleep time/Time spent in bed)
Time frame: Month 6
Sleep latency (in minutes)
Time frame: Month 6
Sleep latency (in minutes)
Time frame: Month 6
Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)(in minutes)
Time frame: Month 6
Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep) (in minutes)
Time frame: Month 6
% of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)
Time frame: Month 6
% of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)
Time frame: Month 6
Number of alarm clocks
Time frame: Month 6
Number of alarm clocks
Time frame: Month 6
Number of position changes
Time frame: Month 6
Number of position changes
Time frame: Month 6
Duration of periodic movements of the lower limbs (in minutes)
Time frame: Month 6
Duration of periodic movements of the lower limbs (in minutes)
Time frame: Month 6
Duration of Cheyne-Stokes periodic breathing (in minutes)
Time frame: Month 6
Duration of Cheyne-Stokes periodic breathing (in minutes)
Time frame: Month 6
number of obstructive and central apneas
Time frame: Month 6
number of obstructive and central apneas
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing night recording in people with Sleep Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective sleep duration (in minutes) (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.