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NCT Number: NCT07628959

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.

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Key information

Conditions

Sleep Disorder (Disorder) Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Mutualiste

Saint-Etienne, 42000, France

Location contact

Bruno STIMMESSE, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C. Santé software compared to polysomnography

Diagnostic Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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.

  5. Differences in measurements across two consecutive nights

    Time frame: Up to 3 months after inclusion

    Differences in measurements across two consecutive nights

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno STIMMESSE, MD

CONTACT

[email protected]

(0)4 82 77 48 58 ext. +33

Clara PFENNINGER, CDP

CONTACT

[email protected]

(0)4 77 12 08 26 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Saint Etienne School of Mine

Registry information

Official study title

Pilot Study of Innovative Sleep Quality Analysis Software Compared With Polysomnography

Acronym: LUNA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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