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Not yet recruitingNCT07867912SOMNOREAUpdated Oct 9, 2026

Evolution of Sleep in Intensive Care Unit Patients

An interventional study of Sleep monitoring using Sleepscan® and Actigraphy in ICU and Sleep Deprivation, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • ICU
  • Sleep Deprivation

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Keywords

  • ICU
  • EEG
  • Circadian rhythm
  • Sleep deprivation
  • Actigraphy
  • Sleepscan
03

In context

Sleep Deprivation

308 studies on the registry are indexed under Sleep Deprivation; 62 are open to participants now.

This study's planned enrollment of 40 is close to the median of 44 across 253 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Sleepscan device and actigraphy

    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

  • OtherSleep 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.

  • OtherActigraphy

    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.

06

What researchers measure

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.)

  5. SOFA score evolution

    Organ failure assessment score at ICU admission and discharge

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

  6. Sleep comparison (ventilated vs non-ventilated patients)

    Median total sleep time comparison between groups

    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.

07

Study locations

1 site
  • CHU de Saint-Etienne
    Saint-Etienne, 42055, France
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for May 2027, 5 months later.

Of 142 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 5 months is below that.

Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 8 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Oct 9, 2026
StartEst.
Dec 2026
Primary completionEst.
May 2027
CompletionEst.
Dec 2027
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07867912
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Dec 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Frédéric ROCHE, MD
Contact
frederic.roche@chu-st-etienne.fr
(0)477828695 ext. +33
Guillaume Thiéry, MD
Contact
Guillaume.Thiery@chu-st-etienne.fr
(0)477127853 ext. +33
Frédéric ROCHE, MD
principal investigator · CHU DE SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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