Evolution of Sleep in Intensive Care Unit Patients

NCT07867912 — Not applicable, Not yet recruiting, 40 participants, Centre Hospitalier Universitaire de Saint Etienne

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Registry	NCT07867912, acronym SOMNOREA
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	40 (Estimated)
Sponsor	Centre Hospitalier Universitaire de Saint Etienne (Other)
Conditions	ICU, Sleep Deprivation
Interventions	Sleep monitoring using Sleepscan®, Actigraphy (Other)
Dates	start 2026-12-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-10-09, last updated 2026-10-09
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sleepscan device and actigraphy	Experimental	Other: Sleep monitoring using Sleepscan®; Other: Actigraphy	Adult ICU patients with expected stay ≥4 days undergoing repeated sleep monitoring using Sleepscan® device and actigraphy, without therapeutic intervention.

Sleep monitoring using Sleepscan® (Other): 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 (Other): 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.

+Outcome measures

Primary outcomes

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®

Secondary outcomes

Total 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 total sleep time (minutes) measured by EEG
Deep 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 of deep sleep stages
Micro-arousal index [Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.]: Number of micro-arousals per hour
ICU length of stay [At ICU discharge (up to 90 days after ICU admission.)]: Duration of ICU hospitalization (days)
SOFA score evolution [At ICU admission and ICU discharge (up to 90 days after ICU admission.)]: Organ failure assessment score at ICU admission and discharge
Sleep comparison (ventilated vs non-ventilated patients) [Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.]: Median total sleep time comparison between groups

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
CHU de Saint-Etienne	Saint-Etienne	France

+Investigators

Frédéric ROCHE, MD, Principal investigator, CHU DE SAINT-ETIENNE