Intensive Care Unit study: Sleepscan device
Official title Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients
ClinicalTrials.gov ID: NCT07606495
What this study is testing
- What it's testing
- The study will see whether better sleep, achieved with real‑time monitoring, reduces the need for mechanical ventilation, death, ICU stay length, and delirium.
- Who it's for
- Awake, conscious ICU patients expected to stay more than 48 hours who do not need urgent intubation.
- What's involved
- Patients wear a sleep‑monitoring device; in the intervention group nurses adjust nighttime care based on the monitor’s sleep data, while the control group receives usual care. All patients have their sleep recorded.
- Time commitment
- Up to 7 days or until ICU discharge, with nightly monitoring from 7 pm to 7 am and routine study assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Poitiers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Poitiers, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.