Intensive Care Unit (ICU)MEDICOSLEEPNCT07606495
Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients
A study testing Sleepscan device and Sleep-guided nursing care in people with Intensive Care Unit (ICU) and Sleep Disruption, run by Poitiers University Hospital at 7 sites in France.
Trial summary
Sleep disturbances are common among intensive care unit (ICU) patients and have been associated with difficult weaning from invasive mechanical ventilation, with an increased risk of endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit (ICU), Sleep Disruption, Sleep Monitoring
- What is being tested?
- Sleepscan device and Sleep-guided nursing care
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 7 sitesFrance
- Study dates
- 16 Sep 2026to Jun 2028
- 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
- Patients aged 18 years or older admitted to an intensive care unit
- Conscious patients with a Richmond Agitation-Sedation Scale (RASS) score between -2 and +1
- Patients without continuous sedation, regardless of ventilatory support
- No indication for urgent intubation (<12 hours)
- Informed consent from the relatives or the patient himself
Who cannot join
- Brain tumor or neuropsychiatric disorders affecting sleep
- Amission for stroke or epilepsy
- Administration of sleep-modifying medication within 24 hours prior to randomization
- Patients with skin lesions around the central right and left areas preclunding the placement of the electrodes
- Patients with expected ICU length of stay less than 48 hours
- Patients with limitation or withdrawal of life-sustaining therapies
Show all 9Show fewer
- Patients already included in the study during a previous hospitalization
- Patients under law protection (guardianship, conservatorship, or judicial protective measures)
- People under protection (minors, persons deprived of liberty by a judicial or administrative decision, patients in emergency situations)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
Vendée Hospital
La Roche-sur-Yon
- Not yet recruiting
La Rochelle Hospital
La Rochelle
- Not yet recruiting
Le Mans Hospital
Le Mans
- Recruiting
Poitiers University Hospital
Poitiers
- Not yet recruiting
Rennes University Hospital
Rennes
- Not yet recruiting
Saintes Hospital
Saintes
- Not yet recruiting
Tours University Hospital
Tours
About this study
Official title: Impact Sur le Pronostic en réanimation d'Une Augmentation du Sommeil Par Soins Nocturnes personnalisés : Essai Clinique randomisé Multicentrique
Sleep disturbances are common among intensive care unit (ICU) patients and have been associated with difficult weaning from invasive mechanical ventilation, with an increased risk of endotracheal intubation. Other studies have reported associations between sleep disturbances and prolonged ICU length of stay or the occurrence of delirium. Among the factors contributing to sleep impairment, nighttime care interventions have been identified as a major cause. The management of sleep disorders in the ICU remains complex and often disappointing, and no pharmacological treatment is currently formally recommended. Very recently, a considerable improvement of sleep quantity (+50%) and quality (doubling of deep sleep quantity) has been reported by reorganizing nighttime nursing care according to patients' sleep cycles, using a sleep monitoring medical device.
The objective of this study is to quantify the impact of a better sleep on prognosis. Sleep will be improved using sleep-guided nursing care during nighttime thanks to a real-time sleep monitor (Sleepscan°).
Read more
The primary endpoint is the proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion. The main secondary outcomes include the duration of ICU stay, the number of delirium free-days, the score at a discomfort scale, the score at a post-traumatic stress disorder scale at ICU discharge. Intensive care unit-related costs will be assessed.
A multi-sites, prospective, randomized, open-label, superiority trial with two parallel arms will be conducted.
Awake and conscious patients without continuous sedation, regardless of ventilatory support, with no indication for urgent intubation (<12 hours) and with an expected ICU length of stay greater than 48 hours will be included.
The intervention will consist of sleep-guided nighttime nursing care using the Sleepscan monitor from 7:00 p.m. to 7:00 a.m., every night until ICU discharge or day 7. Sleep-guided nursing care consist in postponing non urgent care (such as temperature measurement…) and avoiding entering the room when patients are asleep. Otherwise, when patients are awake, instructions are to go for all care, to cluster and anticipate nursing care and perform comfort care.
In the control group, sleep will also be recorded using the same device but the tablet will not display the patient's sleep (or awake) status, and nighttime nursing care will be performed according to usual practice and independently of patients' sleep cycles.
Based on our preliminary data and previous studies, it has been estimated that 230 patients per group will be required to detect a reduction in the proportion of patients intubated or deceased at day 7 from 20% in the control group to 10% in the intervention group.
The intention-to-treat analysis population will include all randomized patients.
Demonstrating an improvement in patient prognosis through enhanced sleep quality would represent a major advancement for intensive care medicine. Reducing the need for invasive mechanical ventilation may lead to shorter ICU stays, lower mortality, fewer post-ICU complications, and reduced hospital costs. Demonstrating an improvement in patient prognosis through enhanced sleep quality would represent a major advancement for intensive care medicine. Reducing the need for invasive mechanical ventilation and the incidence of delirium may lead to shorter ICU stays, lower mortality, fewer post-ICU complications, and reduced hospital costs.
- Being tested
- Sleepscan device, Sleep-guided nursing care
- Keywords
- night-time nurse care, sleep promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleepscan deviceDevice
The Sleepscan® will be installed around 8:00 p.m., for both groups. For the control group, the tablet will not display the sleep/wake status. For the experimental group, the tablet will display the sleep/wake status.
Sleep-guided nursing careProcedure or surgery
Nighttime nursing care will be guided by the Sleepscan device whether the patient is awake or asleep.
When "Prioritize Sleep" signal will be displayed, caregivers may choose to postpone non-urgent care and reduce signal light and sound levels.
When "Prioritize Care" signal will be displayed, caregivers prioritize care will be encouraged.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Standard care with sleep recording using the Sleepscan® device. Receives: Device: Sleepscan device |
| Experimental arm | Experimental | Sleep-guided nursing carewith sleep monitoring using the Sleepscan® device. Receives: Device: Sleepscan device; Procedure: Sleep-guided nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient prognosis
Proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion
Measured: Day 7
Secondary outcomes (15)
ICU length of stay
Number of days in the ICU
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Hospital length of stay
Number of days in the hospital
Measured: Day 90
Need for invasive ventilation
Proportion of patients on invasive ventilation at 7 days.
Measured: Day 7
Death in the intensive care unit
Proportion of patients who died in the intensive care unit
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Delirium free days
Number of days without delirium, as defined by a negative score on the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. The CAM-ICU is considered positive (confusion present) if criteria 1 and 2 + 3 or 4 are met.
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Delirium requiering treatment
Proportion of patients treated for delirium during their stay in the intensive care unit.
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Patient discomfort
Comfort score derived from the Scale of Perceived Discomfort in ICU Patients (IPREA) 18, assessed upon discharge from the ICU. The scale ranges from 0 (minimal discomfort) to 100 (maximum discomfort).
Measured: Day of discharge from the ICU, assessed up to 90 days
Post-traumatic stress symptoms
Proportion of patients with post-traumatic stress disorder upon discharge from the intensive care unit, as assessed using the Revised Impact of Events Scale (IES-R) going from 0 (no post traumatic stress disorder) to 88 (severe post traumatic stress disorder).
Measured: Day of discharge from the ICU, assessed up to 90 days
Insomnia
Average severity of sleep disturbances upon discharge from the intensive care unit, as measured by the Insomnia Severity Index (ISI) going from 0 (non insomnia) to 28 (severe insomnia).
Measured: Day of discharge from the ICU, assessed up to 90 days
ICU-related costs
Average cost of a stay in the intensive care unit from admission to discharge, according to the national cost index
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Patient-reported sleep quality
Average sleep quality perceived by the patient during their stay in the intensive care unit, as measured using the Richard-Campbell Sleep Quality Scale. It is based on five questions regarding falling asleep, sleep depth, the number of awakenings, time spent awake, sleep quality, and noise. A sixth question asks respondents to estimate the extent to which noise disturbs their sleep at night. Each item is scored on a scale of 0 (poor sleep quality) to 100 (high sleep quality).
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Nurses' workload
Average workload for nurses related to sleep-guided nursing care, as measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX). Going from 0 (low workload) to 10 (high work load).
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Sleep duration
Total sleep time in minutes, as measured by the Sleepscan® device.
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Mesured sleep quality
Measured sleep quality will be assessed using three indicators from the Sleepscan® device:
- The duration of sleep spent in episodes lasting > 10 minutes (in minutes and as a percentage).
- The duration of deep sleep in stage N3 (in minutes and as a percentage of total sleep time)
- The duration of REM sleep (in minutes and as a percentage of total sleep time).
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Artifacts of the system
Proportion of nights with more than 50% artifacts
Measured: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start16 Sep 2026
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit (ICU)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606495
- Sponsor's protocol ID
- 2025-A02563-46
- Acronym
- MEDICOSLEEP
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Sur le Pronostic en réanimation d'Une Augmentation du Sommeil Par Soins Nocturnes personnalisés : Essai Clinique randomisé Multicentrique
- ClinicalTrials.gov ID
- NCT07606495
- Acronym / sponsor ID
- MEDICOSLEEP / 2025-A02563-46
- Keywords
- night-time nurse care, sleep promotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 May 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 disturbances are common among intensive care unit (ICU) patients and have been associated with difficult weaning from invasive mechanical ventilation, with an increased risk of endotracheal intubation. Other studies have reported associations between sleep disturbances and prolonged ICU length of stay or the occurrence of delirium. Among the factors contributing to sleep impairment, nighttime care interventions have been identified as a major cause. The management of sleep disorders in the ICU remains complex and often disappointing, and no pharmacological treatment is currently formally recommended. Very recently, a considerable improvement of sleep quantity (+50%) and quality (doubling of deep sleep quantity) has been reported by reorganizing nighttime nursing care according to patients' sleep cycles, using a sleep monitoring medical device.
The objective of this study is to quantify the impact of a better sleep on prognosis. Sleep will be improved using sleep-guided nursing care during nighttime thanks to a real-time sleep monitor (Sleepscan°).
The primary endpoint is the proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion. The main secondary outcomes include the duration of ICU stay, the number of delirium free-days, the score at a discomfort scale, the score at a post-traumatic stress disorder scale at ICU discharge. Intensive care unit-related costs will be assessed.
A multi-sites, prospective, randomized, open-label, superiority trial with two parallel arms will be conducted.
Awake and conscious patients without continuous sedation, regardless of ventilatory support, with no indication for urgent intubation (<12 hours) and with an expected ICU length of stay greater than 48 hours will be included.
The intervention will consist of sleep-guided nighttime nursing care using the Sleepscan monitor from 7:00 p.m. to 7:00 a.m., every night until ICU discharge or day 7. Sleep-guided nursing care consist in postponing non urgent care (such as temperature measurement…) and avoiding entering the room when patients are asleep. Otherwise, when patients are awake, instructions are to go for all care, to cluster and anticipate nursing care and perform comfort care.
In the control group, sleep will also be recorded using the same device but the tablet will not display the patient's sleep (or awake) status, and nighttime nursing care will be performed according to usual practice and independently of patients' sleep cycles.
Based on our preliminary data and previous studies, it has been estimated that 230 patients per group will be required to detect a reduction in the proportion of patients intubated or deceased at day 7 from 20% in the control group to 10% in the intervention group.
The intention-to-treat analysis population will include all randomized patients.
Demonstrating an improvement in patient prognosis through enhanced sleep quality would represent a major advancement for intensive care medicine. Reducing the need for invasive mechanical ventilation may lead to shorter ICU stays, lower mortality, fewer post-ICU complications, and reduced hospital costs. Demonstrating an improvement in patient prognosis through enhanced sleep quality would represent a major advancement for intensive care medicine. Reducing the need for invasive mechanical ventilation and the incidence of delirium may lead to shorter ICU stays, lower mortality, fewer post-ICU complications, and reduced hospital costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Device: Sleepscan deviceStandard care with sleep recording using the Sleepscan® device. |
| Experimental arm | Experimental | Device: Sleepscan device, Procedure: Sleep-guided nursing careSleep-guided nursing carewith sleep monitoring using the Sleepscan® device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older admitted to an intensive care unit
- Conscious patients with a Richmond Agitation-Sedation Scale (RASS) score between -2 and +1
- Patients without continuous sedation, regardless of ventilatory support
- No indication for urgent intubation (<12 hours)
- Informed consent from the relatives or the patient himself
Key exclusion criteria (9 listed)
- Brain tumor or neuropsychiatric disorders affecting sleep
- Amission for stroke or epilepsy
- Administration of sleep-modifying medication within 24 hours prior to randomization
- Patients with skin lesions around the central right and left areas preclunding the placement of the electrodes
- Patients with expected ICU length of stay less than 48 hours
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 |
|---|---|---|
| Sleepscan deviceThe Sleepscan® will be installed around 8:00 p.m., for both groups. For the control group, the tablet will not display the sleep/wake status. For the experimental group, the tablet will display the sleep/wake status. | Device | Control arm, Experimental arm |
| Sleep-guided nursing careNighttime nursing care will be guided by the Sleepscan device whether the patient is awake or asleep. When "Prioritize Sleep" signal will be displayed, caregivers may choose to postpone non-urgent care and reduce signal light and sound levels. When "Prioritize Care" signal will be displayed, caregivers prioritize care will be encouraged. | Procedure or surgery | Experimental arm |
Primary outcome
Patient prognosis
Time frame: Day 7
Proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion
15 secondary outcomes
ICU length of stay
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Hospital length of stay
Time frame: Day 90
Need for invasive ventilation
Time frame: Day 7
Death in the intensive care unit
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Delirium free days
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Delirium requiering treatment
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Patient discomfort
Time frame: Day of discharge from the ICU, assessed up to 90 days
Post-traumatic stress symptoms
Time frame: Day of discharge from the ICU, assessed up to 90 days
Insomnia
Time frame: Day of discharge from the ICU, assessed up to 90 days
ICU-related costs
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Patient-reported sleep quality
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Nurses' workload
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Sleep duration
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Mesured sleep quality
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Artifacts of the system
Time frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepscan device and Sleep-guided nursing care in people with Intensive Care Unit (ICU) and Sleep Disruption, run by Poitiers University Hospital at 7 sites 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Xavier DROUOT (+33549444444, xavier.drouot@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient prognosis (time frame: Day 7). 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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.