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

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

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")

Study Overview

• Status: Recruiting
• Conditions: Sleep Quality; Intensive Care Unit; Critically Ill Patient
• Intervention / Treatment: Device: EEG-guided sleep protection; Other: Control condition

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xavier DROUOT, Pr; Phone Number: +33 05 49 44 34 65; Email: xavier.drouot@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • CHU Poitiers
    • Contact: THILLE Arnaud, Pr; Email: arnaud.thille@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Usual Care	Other: Control condition; 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.
Experimental: EEG-guided sleep protection	Device: EEG-guided sleep protection; 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.

What is the study measuring?

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
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
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
Safety of the procedure	Numbers of Serious adverse events and Material defect events	One day after Unit Care discharge, an average of 15 days
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 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
Unit Care length of stay	Number of days in ICU	At Unit care discharge, an average of 14 days

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): August 8, 2024
• Study Completion (Estimated): August 27, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: SleepScan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No