Sleep Disorder (Disorder)LUNANCT07628959
Innovative Sleep Quality Analysis Software Compared With Polysomnography
A study testing C. Santé software compared to polysomnography in people with Sleep Disorder (Disorder), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder (Disorder)
- What is being tested?
- C. Santé software compared to polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Sleep Disorder (Disorder)
- Being tested
- C. Santé software compared to polysomnography
- Keywords
- polysomnography, BCG, Sleep Disorders
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. Santé software compared to polysomnographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Polysomnography | Experimental | The patients will spend two consecutive nights on the bed equipped with C. Santé software which is also equipped with traditional polysomnography. Receives: Diagnostic Test: C. Santé software compared to polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "Up to 3 months after inclusion
Secondary outcomes (5)
Accuracy of RR interval measurement
Determined from the ECG trace of the PSG compared to the C. Santé software
Measured: Up to 3 months after inclusion
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.
Measured: Up to 3 months after inclusion
Accuracy of respiratory rate measurement
Comparing C. Santé software measurements to nasal cannula measurements from PSG (analyzed in 30-second intervals)
Measured: Up to 3 months after inclusion
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.
Measured: Up to 3 months after inclusion
Differences in measurements across two consecutive nights
Differences in measurements across two consecutive nights
Measured: Up to 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Etienne School of Mine
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, MD PhD, Study chair, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628959
- Sponsor's protocol ID
- 25CH123
- Other IDs
- ANSM
- Acronym
- LUNA
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Innovative Sleep Quality Analysis Software Compared With Polysomnography
- ClinicalTrials.gov ID
- NCT07628959
- Acronym / sponsor ID
- LUNA / 25CH123
- Conditions
- Sleep Disorder (Disorder)
- Keywords
- polysomnography, BCG, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Saint Etienne School of Mine
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polysomnography | Experimental | Diagnostic Test: C. Santé software compared to polysomnographyThe patients will spend two consecutive nights on the bed equipped with C. Santé software which is also equipped with traditional polysomnography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C. Santé software compared to polysomnographyPatients 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. | Diagnostic test | Polysomnography |
Primary outcome
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.
5 secondary outcomes
Accuracy of RR interval measurement
Time frame: Up to 3 months after inclusion
Accuracy of sleep phase duration measurement
Time frame: Up to 3 months after inclusion
Accuracy of respiratory rate measurement
Time frame: Up to 3 months after inclusion
Accuracy in positional data
Time frame: Up to 3 months after inclusion
Differences in measurements across two consecutive nights
Time frame: Up to 3 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric ROCHE, MD PhD study chair
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C. Santé software compared to polysomnography in people with Sleep Disorder (Disorder), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno STIMMESSE, MD ((0)4 82 77 48 58 ext. +33, bstimmesse@mutualite-loire.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG). (time frame: "Up to 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.