Pilot Study of Innovative Sleep Quality Analysis Software Compared With Polysomnography (LUNA)

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 Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder (Disorder)
• Intervention / Treatment: Diagnostic test: C. Santé software compared to polysomnography

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno STIMMESSE, MD; Phone Number: +33 (0)4 82 77 48 58; Email: bstimmesse@mutualite-loire.com
• Study Contact Backup: Name: Clara PFENNINGER, CDP; Phone Number: +33 (0)4 77 12 08 26; Email: clara.pfenninger@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42000
    • Clinique Mutualiste
    • Principal Investigator: Bruno STIMMESSE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Polysomnography; The patients will spend two consecutive nights on the bed equipped with C. Santé software which is also equipped with traditional polysomnography.

Diagnostic test: C. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two consecutive nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of RR interval measurement	Determined from the ECG trace of the PSG compared to the C. Santé software	two consecutive nights
Accuracy of sleep phase duration measurement	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.	two consecutive nights
Accuracy of respiratory rate measurement	Comparing C. Santé software measurements to nasal cannula measurements from PSG (analyzed in 30-second intervals)	Two consecutive nights.
Accuracy in positional data	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.	Two consecutive nights
Differences in measurements across two consecutive nights	Differences in measurements across two consecutive nights	Two consecutive nights

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Saint Etienne School of Mine
• Investigators: Study Chair: Frédéric ROCHE, MD PhD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: polysomnography; Sleep Disorders; BCG
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders
• Other Study ID Numbers: 25CH123; ANSM (Other Identifier: 2025-A02220-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No