Innovative Sleep Quality Analysis Software Compared With Polysomnography
France33 participantsStarted 2026-06
Plain-language summary
To diagnose sleep disorders, practitioners primarily use polysomnography (PSG), a precise but costly, cumbersome method that is limited to a single observation. This does not allow for longitudinal monitoring of sleep habits in real-world conditions. An alternative is offered with the C. Santé software receiving information from sensors installed on medical bed. This software analyzes cardiorespiratory parameters and sleep phases without disturbing the patient, enabling continuous and comfortable monitoring. A preliminary study aims to validate the reliability of the C. Santé software analysis, by comparing it to the PSG analysis, considered the gold standard.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged over 18 years.
* Patients affiliated with or beneficiaries of a social security system.
* Patients capable of completing all aspects of the study.
* Patients who have signed informed consent for participation in the study
Exclusion Criteria:
* pregnancy
* Patients suffering from an acute bacterial, fungal, or viral infection.
* Patients unable to tolerate the placement of the PSG.
* Patients with psychiatric disorders incompatible with the constraints associated with the need to spend two nights at the clinic.
* restless legs syndrome
* Presence of a cardiac pacemaker.
* Cardiac arrhythmia problems (e.g., complete arrhythmia).
* Known and treated sleep disorders (e.g., sleep apnea syndrome) or uncontrolled chronic insomnia.
* Diagnosed dementia.
* Simultaneous participation in other research studies.
* Use of medications that could alter sleepiness, including:
* Sedative-hypnotics.
* Neuroleptics.
* Antidepressants.
* Anxiolytics.
* H1 antihistamines.
* Antiepileptics.
* Opiates and opioid analgesics.
* Patients under legal guardianship or curatorship.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG).
Timeframe: "Up to 3 months after inclusion
Trial details
NCT IDNCT07628959
SponsorCentre Hospitalier Universitaire de Saint Etienne