Clinical trial NCT05963672: Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit
Official title: Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Critically Ill Patient
Intensive Care Unit
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Sleep of critically ill patients is highly disturbed with a high sleep fragmentation; patients spend most of their sleep in very short sleep episodes, lasting less than 10 minutes. Causes of theses sleep alterations are complex including environmental noise (alarms, beepers, conversations...), continuous light, nurse care and repetitive measures of vital parameters.

Numerous studies have reported a relationship between severe sleep alterations and a prolonged weaning period and mortality. Improving sleep quality in critically ill patients is a major challenge to promote ICU patient's recovery.

A very promising treatment is the application of a nocturnal " quiet-time " during which non urgent care, comfort care, systematic measures of vital parameters are delayed and clustered in order to limit room entries. However, " quiet time " procedures have failed to improve sleep quality to date.

A miniaturized medical device recording one EEG channel and embedding an automated sleep scoring algorithm running in real-time was devised. This device (positioned on forehead, and continuously recording noise and light levels) indicates if the patient is awake or asleep using a tablet positioned at doorstep of the room, so that nurses know if patient is sleeping, without entering the room.

Hypothesis proposes that applying sleep protection procedures (clustering cares, limiting room entries, reducing lights and noise, delaying non urgent care...) when patients are sleeping (= EEG-guided strategies) will increase patients sleep quality.

This study will assess the effect of such device on sleep quality in ICU patients. This is a "before / after" design. The first group ("control group"), will be recorded but the sleep scoring will not be displayed by the tablet and patient will be expose to standard care. Then, procedure will be established collegially with nurses, nurses assistants and doctors. Then, the second group ("treated group") will be recorded with the device displaying the status of the patient (asleep/awake) and all caregivers will be asked to follow the established rules ("EEG-guided sleep protection rules")


Eligibility criteria: Inclusion Criteria:

* Adults admitted in medical ICU of University Hospital of Poitiers

  * Un-sedated patients displaying a RASS scale between -2 and +1
  * Intubated or spontaneously breathing patients
  * Patient or family have signed the inform consent

Exclusion Criteria:

* Patients with a central nervous system disease altering sleep scoring
* Patients who received drugs (\<24h) modifying significantly EEG and sleep scoring
* Patients with cutaneous erosion of the scalp

Primary outcomes:
measure: Sleep quality
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: Sleep fragmentation
timeFrame: Day 1 to Day 4
measure: Environmental noise and environmental light
timeFrame: Day 1 to Day 4
measure: Sleep interruptions by caregivers
timeFrame: Day 1 to Day 4
measure: Sleep quality
timeFrame: Day 2 to Day 4
measure: Workload assessed by nurses
timeFrame: Day 1 to Day 4
measure: Patient Agitation
timeFrame: Day 1 to day 4
measure: Performance of the algorithm
timeFrame: Day 1 to Day 4
measure: Patient reported sleep quality
timeFrame: Day 1 to day 4
measure: Anxiety level
timeFrame: Day 1 to day 4
measure: Respiratory status
timeFrame: At Unit care discharge, an average of 14 days
measure: Presence of delirium
timeFrame: Day 1 to Day 4
measure: Unit Care length of stay
timeFrame: At Unit care discharge, an average of 14 days
measure: Safety of the procedure
timeFrame: One day after Unit Care discharge, an average of 15 days
measure: Sleep continuity
timeFrame: Day 1 to Day 4
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References: