Personalized Night-time Nursing to Improve Sleep in Critically Ill Patients
Official title: Impact Sur le Pronostic en réanimation d'Une Augmentation du Sommeil Par Soins Nocturnes personnalisés : Essai Clinique randomisé Multicentrique
Run by Poitiers University Hospital · NCT07606495 · Data updated 2026-11-12
This study tests whether sleep-guided nursing, aided by a sleep-monitoring device, can improve sleep quality for adults in the ICU and whether that helps their prognosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 460 (estimated) |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 7 sites (La Roche-sur-Yon and 6 other locations) |
| Status | Recruiting |
| Started | September 16, 2026 |
| Main results expected | March 2028 |
| Study ends | June 2028 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07606495 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults admitted to the ICU who are alert or lightly sedated, not requiring urgent intubation, and able to provide or have a surrogate provide consent.
✕Probably not a fit
Patients with severe brain injury, active neuropsychiatric sleep disorders, recent sleep medication use, or imminent withdrawal of life support may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses the Sleepscan device to guide nighttime nursing care for ICU patients. Eligible participants are adults in the ICU with stable consciousness and no urgent need for intubation, and who are not on continuous sedation. The goal is to see if tailoring care to a patient’s sleep cycle can improve sleep quantity and sleep stages, and whether better sleep translates to better prognosis. The study excludes patients with certain brain or sleep disorders, recent sleep-modifying meds, or short expected stays. Outcomes focus on sleep improvement and related clinical prognosis in a real-world ICU setting across multiple hospitals.
Why it matters
Potential benefit: If successful, patients could experience better sleep quality in the ICU, which may support faster weaning from ventilation and shorter stays.
How similar studies have gone: Preliminary reports have shown sleep improvements with sleep-guided nursing, but full-scale evidence on prognosis is still evolving.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Poitiers University Hospital
Poitiers, France Recruiting -
Vendée Hospital
La Roche-sur-Yon, France Not yet recruiting -
La Rochelle Hospital
La Rochelle, France Not yet recruiting -
Le Mans Hospital
Le Mans, France Not yet recruiting -
Rennes University Hospital
Rennes, France Not yet recruiting -
Saintes Hospital
Saintes, France Not yet recruiting
Show 1 more location
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Tours University Hospital
Tours, France Not yet recruiting
Study contacts
- Study coordinator: Xavier DROUOT
- Email: xavier.drouot@chu-poitiers.fr
- Phone: +33549444444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.