Menu
Not yet recruiting NCT07628959

Innovative Sleep Quality Analysis Software Compared With Polysomnography

No phase Interventional Sleep Disorder (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C. Santé software compared to polysomnography.
Who it may be relevant to
Registry conditions: Sleep Disorder (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study of Innovative Sleep Quality Analysis Software Compared With Polysomnography

Overview

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.

Interventions

  • 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 sensor

Primary outcome measures

  • The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG). [Time frame: "Up to 3 months after inclusion]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Clinique Mutualiste — Saint-Etienne

Identifiers

NCT: NCT07628959 · 25CH123 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗