Innovative Sleep Quality Analysis Software Compared With Polysomnography

N/ANot Yet RecruitingNCT07628959

Centre Hospitalier Universitaire de Saint Etienne33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sleep Disorder (Disorder)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG).

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.

Time frame: "Up to 3 months after inclusion