Innovative Sleep Quality Analysis Software Compared With Polysomnography (LUNA)
8. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bruno STIMMESSE, MD
- Telefonnummer: +33 (0)4 82 77 48 58
- E-mail: bstimmesse@mutualite-loire.com
Undersøgelse Kontakt Backup
- Navn: Clara PFENNINGER, CDP
- Telefonnummer: +33 (0)4 77 12 08 26
- E-mail: clara.pfenninger@chu-st-etienne.fr
Studiesteder
-
-
-
Saint-Etienne, Frankrig, 42000
- Clinique Mutualiste
-
Ledende efterforsker:
- Bruno STIMMESSE, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Polysomnography
The patients will spend two consecutive nights on the bed equipped with C. Santé software which is also equipped with traditional 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG).
Tidsramme: "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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of RR interval measurement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 3 months after inclusion
|
Differences in measurements across two consecutive nights
|
Up to 3 months after inclusion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Frédéric ROCHE, MD PhD, CHU de Saint-Etienne
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
1. juni 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25CH123
- ANSM (Anden identifikator: 2024-A02435-42)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .