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

RecruitingNAAges 18 Years - anyAllPoitiers University Hospital
NCT07606495 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 qua

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📋 Eligibility rules (as published)
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)
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What it tests

  • Sleepscan device
  • Sleep-guided nursing care
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Where

7 sites
Vendée Hospital
La Roche-sur-Yon, France
La Rochelle Hospital
La Rochelle, France
Le Mans Hospital
Le Mans, France
Poitiers University Hospital
Poitiers, France
Rennes University Hospital
Rennes, France
Saintes Hospital
Saintes, France
Tours University Hospital
Tours, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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