Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients (MEDICOSLEEP)

May 26, 2026 updated by: Poitiers University Hospital

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°).

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

460

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
Standard care with sleep recording using the Sleepscan® device.
Device: Sleepscan device
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.
Experimental: Experimental arm
Sleep-guided nursing carewith sleep monitoring using the Sleepscan® device.
Device: Sleepscan device
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.
Procedure: Sleep-guided nursing care

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient prognosis
Time Frame: Day 7
Proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Number of days in the ICU
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
Number of days in the hospital
Day 90
Need for invasive ventilation
Time Frame: Day 7
Proportion of patients on invasive ventilation at 7 days.
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
Proportion of patients who died in the intensive care unit
From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Delirium requiering treatment
Time Frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Proportion of patients treated for delirium during their stay in the intensive care unit.
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
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).
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
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).
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
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).
Day 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
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).
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
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).
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
Total sleep time in minutes, as measured by the Sleepscan® device.
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

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).
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
Proportion of nights with more than 50% artifacts
From date of randomization until the date of discharge from the ICU, assessed up to 7 days
Delirium free days
Time Frame: From date of randomization until the date of discharge from the ICU, assessed up to 7 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.
From date of randomization until the date of discharge from the ICU, assessed up to 7 days
ICU-related costs
Time Frame: From date of randomization until the date of discharge from the ICU, assessed up to 90 days
Average cost of a stay in the intensive care unit from admission to discharge, according to the national cost index
From date of randomization until the date of discharge from the ICU, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-A02563-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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