Evolution of Sleep in Intensive Care Unit Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Affiliated to a social security system
Informed consent obtained (patient or proxy if necessary)
Expected ICU stay ≥ 4 days
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sleep monitoring using Sleepscan®
Other interventionNon-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 interventionAn 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Sleepscan device and actigraphyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Median continuous sleep time
Median duration (in minutes) of continuous sleep episodes ≥10 minutes measured using EEG recordings via Sleepscan®
Time frame
Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.Secondary outcomes
1
Total sleep time
Median total sleep time (minutes) measured by EEG
Time frame
Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.2
Deep sleep time
Median duration of deep sleep stages
Time frame
Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.3
Micro-arousal index
Number of micro-arousals per hour
Time frame
Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.4
ICU length of stay
Duration of ICU hospitalization (days)
Time frame
At ICU discharge (up to 90 days after ICU admission.)Sponsors and contacts
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Source ClinicalTrials.gov
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