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

Официальное название

Impact Sur le Pronostic en réanimation d'Une Augmentation du Sommeil Par Soins Nocturnes personnalisés : Essai Clinique randomisé Multicentrique

Обзор

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.

Вмешательства

• Устройство 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.
• Процедура 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.

Первичные конечные точки

• Patient prognosis [Срок оценки: Day 7]

Вторичные конечные точки (12)

• ICU length of stay [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 90 days]
• Hospital length of stay [Срок оценки: Day 90]
• Need for invasive ventilation [Срок оценки: Day 7]
• Death in the intensive care unit [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 90 days]
• Delirium free days [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 7 days]
• Delirium requiering treatment [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 7 days]
• Patient discomfort [Срок оценки: Day of discharge from the ICU, assessed up to 90 days]
• Post-traumatic stress symptoms [Срок оценки: Day of discharge from the ICU, assessed up to 90 days]
• Insomnia [Срок оценки: Day of discharge from the ICU, assessed up to 90 days]
• ICU-related costs [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 90 days]
• Patient-reported sleep quality [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 7 days]
• Nurses' workload [Срок оценки: From date of randomization until the date of discharge from the ICU, assessed up to 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07606495 · 2025-A02563-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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