Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit

Study Overview
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Brief Summary
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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)

Official Title
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Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)

Conditions
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Sleep Quality, Critically Ill Patient, Intensive Care Unit

Intervention / Treatment
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* Device: EEG-guided sleep protection
* Other: Control condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Usual Care<br> | Other: Control condition<br>* the recording device will be placed on the patient to record sleep but the tablet will be masked and placed face down on the bench in the room, invisible from the door.<br>|
| Experimental: EEG-guided sleep protection<br> | Device: EEG-guided sleep protection<br>* The tablet will display a specific picture prioritize sleep or prioritize care depending on the patient status determined by the algorithm. When the picture favor/prioritize sleep is displayed, all caregivers and visiting family are asked to follow the sleep protection rules: refrain to enter the room for not urgent reasons, switch off television, reduced light in the room/corridor, reduce noise in front of the door, close curtain (if any), and delay non urgent care…etc; if caregivers have to enter the room, headlight and/or additional light will be favored. All these rules will be established collegially by nurses and doctors. Obviously, urgent care and reactions to alarms are maintained. When the picture favor/prioritize care is displayed, all caregivers and visiting family are invited to perform non urgent care, cleaning, restocking perfusion needles, comfort care, visiting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Proportion of continuous sleep | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep fragmentation | Number of arousals and awakenings per hour of sleep | Day 1 | 
| Environmental noise and environmental light | Number of peak noise end time spent above 20 lux | Day 1 to Day 4 | 
| Sleep interruptions by caregivers | Number of room entries while patient is asleep | Day 1 to Day 4 | 
| Sleep quality | Proportion of continuous sleep | Day 2 to Day 4 | 
| Workload assessed by nurses | Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload. | Day 1 to Day 4 | 
| Patient Agitation | Number of patients with diminishing (-1 point) Richmond Agitation-Sedation Scale (RASS) score. 10 Agitation-Sedation scale items From +4 (combative) to -5 (non-recoverable) | Day 1 to day 4 | 
| Performance of the algorithm | Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring) | Day 1 | 
| Patient reported sleep quality | Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep | Day 1 to day 4 | 
| Anxiety level | Score at Spielberger Y-A scale.It consist of 12 questions, each rated on a scale with 4 response options. Lower score means a minimal anxiety level. | Day 1 to day 4 | 
| Respiratory status | Weaning duration (number of days), ventilator free days and respiratory status at discharge | At Unit care discharge, an average of 14 days | 
| Presence of delirium | Number of days with positive Confusion Assessment Method(CAM)-ICU scale. It is made up of 4 criteria. The test is POSITIVE (confusion present) if 1 and 2 + 3 or 4 are met. | Day 1 to Day 4 | 
| Unit Care length of stay | Number of days in ICU | At Unit care discharge, an average of 14 days | 
| Safety of the procedure | Numbers of Serious adverse events and Material defect events | One day after Unit Care discharge, an average of 15 days |