Sleep Disorder (Disorder)
Conditions
Keywords
polysomnography, BCG, Sleep Disorders
Brief 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.
Interventions
DIAGNOSTIC_TESTC. Santé software compared to polysomnography
Patients visit the Sleep Unit at the Clinique Mutualiste for sleep disorders. During their consultation with the doctor, a polysomnography scheduled over two consecutive nights is proposed (this applies to any diagnosis of sleep disorders). At that time, they are also invited to participate in the study. After receiving information about the study and signing the consent form, the patient returns for their two consecutive nights equipped with PSG, which they spend on the bed equipped with sensors transmitting information to C. Santé software.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Saint Etienne School of Mine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG). | "Up to 3 months after inclusion | The study's objective will be met if the sleep efficiency measured by PSG and that calculated from C. Santé software differ by no more than 10%. This means the device will be considered effective if there is at least 90% agreement between PSG and the C. Santé software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of RR interval measurement | Up to 3 months after inclusion | Determined from the ECG trace of the PSG compared to the C. Santé software |
| Accuracy of sleep phase duration measurement | Up to 3 months after inclusion | Comparing PSG-calculated durations for sleep stages (N1: light slowwave sleep, N2: intermediate slow-wave sleep, N3: deep slow-wave sleep, REM: rapid eye movement sleep) to the C. Santé software calculation for slow-wave sleep (N) and REM. |
| Accuracy of respiratory rate measurement | Up to 3 months after inclusion | Comparing C. Santé software measurements to nasal cannula measurements from PSG (analyzed in 30-second intervals) |
| Accuracy in positional data | Up to 3 months after inclusion | Comparing the time spent lying on the back or side and the number of position changes as calculated by PSG (via a thoracic accelerometer) and by C. Santé software. |
| Differences in measurements across two consecutive nights | Up to 3 months after inclusion | Differences in measurements across two consecutive nights |
Countries
France
Contacts
CONTACTBruno STIMMESSE, MD
CONTACTClara PFENNINGER, CDP
STUDY_CHAIRFrédéric ROCHE, MD PhD
CHU de Saint-Etienne
Outcome results
None listed