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Starting soon Not applicable

Evolution of Sleep in Intensive Care Unit Patients

NCT07867912 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-12
Last updated
2026-10-09

Condition(s) studied

ICUSleep Deprivation

Investigational drug(s) / intervention(s)

Sleep monitoring using Sleepscan®Actigraphy

Sleep monitoring using Sleepscan®: Non-invasive EEG-based sleep monitoring using the Sleepscan® device. Three scalp electrodes (frontal, mastoid, central) are applied with a headband for overnight recordings (12 hours, 8 PM-8 AM) during four nights (N1, N2, N3, and last night before discharge). Data are automatically analyzed and secondarily reviewed.

Actigraphy: An actimeter placed on the ankle to measure motor activity and estimate sleep-wake cycles during the first 72 hours and the last 24 hours of ICU stay.

Study summary

Sleep plays a key role in immune, metabolic, and neurological regulation, particularly in critically ill patients. However, the intensive care environment significantly disrupts sleep due to noise, light exposure, and frequent medical interventions, leading to circadian rhythm disturbances. Poor sleep in ICU patients is associated with increased morbidity, mortality, prolonged mechanical ventilation, and long-term psychological complications. Current studies report fragmented sleep with reduced deep sleep stages but are limited by short monitoring periods and small sample sizes. No study has yet assessed longitudinal sleep evolution throughout ICU stay. This study aims to characterize sleep dynamics from the acute phase to recovery using a simplified EEG device (Sleepscan®). Sleep will be recorded during the first three nights and the last night before ICU discharge. Environmental factors (noise, light) and clinical data will also be collected. This longitudinal intra-individual analysis will identify critical periods of sleep disruption. Results may guide future targeted interventions to improve sleep quality and patient outcomes in ICU.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients * Affiliated to a social security system * Informed consent obtained (patient or proxy if necessary) * Expected ICU stay ≥ 4 days Exclusion Criteria: * Acute brain injury or neurological disease (stroke, meningitis, neurodegenerative disease) * Severe psychiatric disorders, dementia, or agitation Sedated patients (RASS \< 0) * Patients under legal protection (guardianship) * Pregnant women * Skin lesions preventing electrode placement

Primary outcome measure(s)

  • Median continuous sleep time — Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.
    Median duration (in minutes) of continuous sleep episodes ≥10 minutes measured using EEG recordings via Sleepscan®

Trial sites (1)

FacilityCityRegionStatus
CHU de Saint-Etienne Saint-Etienne France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07867912 on ClinicalTrials.gov ↗ ← All trials in France