Innovative Sleep Quality Analysis Software Compared With Polysomnography (LUNA)

June 8, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

Pilot Study of Innovative Sleep Quality Analysis Software Compared With Polysomnography

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG).
Time Frame: "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.
"Up to 3 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of RR interval measurement
Time Frame: Up to 3 months after inclusion
Determined from the ECG trace of the PSG compared to the C. Santé software
Up to 3 months after inclusion
Accuracy of sleep phase duration measurement
Time Frame: 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.
Up to 3 months after inclusion
Accuracy of respiratory rate measurement
Time Frame: Up to 3 months after inclusion
Comparing C. Santé software measurements to nasal cannula measurements from PSG (analyzed in 30-second intervals)
Up to 3 months after inclusion
Accuracy in positional data
Time Frame: 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.
Up to 3 months after inclusion
Differences in measurements across two consecutive nights
Time Frame: Up to 3 months after inclusion
Differences in measurements across two consecutive nights
Up to 3 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Saint Etienne School of Mine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Frédéric ROCHE, MD PhD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25CH123
  • ANSM (Other Identifier: 2025-A02337-42)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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