ICUSOMNOREANCT07867912
Evolution of Sleep in Intensive Care Unit Patients
A study testing Sleep monitoring using Sleepscan® and Actigraphy in people with ICU and Sleep Deprivation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU, Sleep Deprivation
- What is being tested?
- Sleep monitoring using Sleepscan® and Actigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Affiliated to a social security system
- Informed consent obtained (patient or proxy if necessary)
- Expected ICU stay ≥ 4 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Saint-Etienne
Saint-Etienne, 42055
Frédéric ROCHE, MD, (0)477828695 ext. +33, frederic.roche@chu-st-etienne.fr
Guillaume Thiéry, MD
About this study
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
- Being tested
- Sleep monitoring using Sleepscan®, Actigraphy
- Keywords
- ICU, EEG, Circadian rhythm, Sleep deprivation, Actigraphy, Sleepscan
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ActigraphyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sleep monitoring using Sleepscan®; Other: Actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median continuous sleep time
Median duration (in minutes) of continuous sleep episodes ≥10 minutes measured using EEG recordings via Sleepscan®
Measured: 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
Median total sleep time (minutes) measured by EEG
Measured: 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
Median duration of deep sleep stages
Measured: 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
Number of micro-arousals per hour
Measured: 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
Duration of ICU hospitalization (days)
Measured: At ICU discharge (up to 90 days after ICU admission.)
SOFA score evolution
Organ failure assessment score at ICU admission and discharge
Measured: At ICU admission and ICU discharge (up to 90 days after ICU admission.)
Sleep comparison (ventilated vs non-ventilated patients)
Median total sleep time comparison between groups
Measured: Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICUStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, MD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867912
- Sponsor's protocol ID
- 24CH178
- Other IDs
- ANSM
- Acronym
- SOMNOREA
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Sleep in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07867912
- Acronym / sponsor ID
- SOMNOREA / 24CH178
- Conditions
- ICU, Sleep Deprivation
- Keywords
- ICU, EEG, Circadian rhythm, Sleep deprivation, Actigraphy, Sleepscan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleepscan device and actigraphy | Experimental | Other: Sleep monitoring using Sleepscan®, Other: ActigraphyAdult ICU patients with expected stay ≥4 days undergoing repeated sleep monitoring using Sleepscan® device and actigraphy, without therapeutic intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Affiliated to a social security system
- Informed consent obtained (patient or proxy if necessary)
- Expected ICU stay ≥ 4 days
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Sleepscan device and actigraphy |
| ActigraphyAn 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. | Other | Sleepscan device and actigraphy |
Primary outcome
Median continuous sleep time
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.
Median duration (in minutes) of continuous sleep episodes ≥10 minutes measured using EEG recordings via Sleepscan®
6 secondary outcomes
Total sleep time
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.
Deep sleep time
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.
Micro-arousal index
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.
ICU length of stay
Time frame: At ICU discharge (up to 90 days after ICU admission.)
SOFA score evolution
Time frame: At ICU admission and ICU discharge (up to 90 days after ICU admission.)
Sleep comparison (ventilated vs non-ventilated patients)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric ROCHE, MD principal investigator
CHU DE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep monitoring using Sleepscan® and Actigraphy in people with ICU and Sleep Deprivation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric ROCHE, MD ((0)477828695 ext. +33, frederic.roche@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median continuous sleep time (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.