Innovative Sleep Quality Analysis Software Compared With Polysomnography
Starting soon · Not applicable
Conditions studied: Sleep Disorder (Disorder)
In brief
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.
Key facts
- Study ID
- NCT07628959
- Run by
- Centre Hospitalier Universitaire de Saint Etienne
- People needed
- 33
- Starts
- 2026-06-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Clinique Mutualiste — Saint-Etienne, France
Full record on ClinicalTrials.gov
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