Evolution of Sleep in Intensive Care Unit Patients

NCT07867912 | Not Yet Recruiting

• 2 other identifiers: 24CH178ANSM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ICU; Sleep Deprivation

Keywords

ICU; EEG; Circadian rhythm; Sleep deprivation; Actigraphy; Sleepscan

Outcome Measures

Primary Outcomes (1)

• Median continuous sleep time

  Median duration (in minutes) of continuous sleep episodes ≥10 minutes measured using EEG recordings via Sleepscan®

  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 (6)

• 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.

• 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.

• 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.

• ICU length of stay

  At ICU discharge (up to 90 days after ICU admission.)

• SOFA score evolution

  At ICU admission and ICU discharge (up to 90 days after ICU admission.)

Study Arms (1)

Sleepscan device and actigraphy

EXPERIMENTAL

Adult ICU patients with expected stay ≥4 days undergoing repeated sleep monitoring using Sleepscan® device and actigraphy, without therapeutic intervention.

Other: Sleep monitoring using Sleepscan®; Other: Actigraphy

Interventions

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.

Sleepscan device and actigraphy

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.

Sleepscan device and actigraphy

Eligibility Criteria

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

You may qualify if:

• Adult patients
• Affiliated to a social security system
• Informed consent obtained (patient or proxy if necessary)
• Expected ICU stay ≥ 4 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Frédéric ROCHE, MD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric ROCHE, MD

CONTACT

(0)477828695; frederic.roche@chu-st-etienne.fr

Guillaume Thiéry, MD

CONTACT

(0)477127853; Guillaume.Thiery@chu-st-etienne.fr

Study Design

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

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-09

Locations

FR (1)