Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients (MEDICOSLEEP)
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Control arm
Standard care with sleep recording using the 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.
|
|
Experimentální: Experimental arm
Sleep-guided nursing carewith sleep monitoring using the 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.
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient prognosis
Časové okno: Day 7
|
Proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion
|
Day 7
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
ICU length of stay
Časové okno: 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
Časové okno: Day 90
|
Number of days in the hospital
|
Day 90
|
|
Need for invasive ventilation
Časové okno: Day 7
|
Proportion of patients on invasive ventilation at 7 days.
|
Day 7
|
|
Death in the intensive care unit
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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:
|
From date of randomization until the date of discharge from the ICU, assessed up to 7 days
|
|
Artifacts of the system
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2025-A02563-46
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .