Innovative Sleep Quality Analysis Software Compared With Polysomnography

NCT07628959 | Not Yet Recruiting

• 2 other identifiers: 25CH123ANSM
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

polysomnography; BCG; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  "Up to 3 months after inclusion

Secondary Outcomes (5)

• Accuracy of RR interval measurement

  Up to 3 months after inclusion

• Accuracy of sleep phase duration measurement

  Up to 3 months after inclusion

• Accuracy of respiratory rate measurement

  Up to 3 months after inclusion

• Accuracy in positional data

  Up to 3 months after inclusion

• Differences in measurements across two consecutive nights

  Up to 3 months after inclusion

Study Arms (1)

Polysomnography

EXPERIMENTAL

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

Interventions

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.

Polysomnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Saint Etienne School of Mine: collaborator

Study Sites (1)

Clinique Mutualiste

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Frédéric ROCHE, MD PhD

  CHU de Saint-Etienne

  STUDY CHAIR

Central Study Contacts

Bruno STIMMESSE, MD

CONTACT

(0)4 82 77 48 58; bstimmesse@mutualite-loire.com

Clara PFENNINGER, CDP

CONTACT

(0)4 77 12 08 26; clara.pfenninger@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)