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

Intensive Care Unit Clinical Trial

— SleepScan  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963672
• Other study ID #: SleepScan
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: August 27, 2024

Study information

• Verified date: August 2023
• Source: Poitiers University Hospital
• Contact: Xavier DROUOT, Pr
• Phone: 05 49 44 34 65
• Email: xavier.drouot[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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")

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 27, 2024
• Est. primary completion date: August 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patient
• Intensive Care Unit
• Sleep Quality

Intervention

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.

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.

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality	Proportion of continuous sleep	Day 1
Secondary	Sleep fragmentation	Number of arousals and awakenings per hour of sleep	Day 1
Secondary	Environmental noise and environmental light	Number of peak noise end time spent above 20 lux	Day 1 to Day 4
Secondary	Sleep interruptions by caregivers	Number of room entries while patient is asleep	Day 1 to Day 4
Secondary	Sleep quality	Proportion of continuous sleep	Day 2 to Day 4
Secondary	Workload assessed by nurses	Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.	Day 1 to Day 4
Secondary	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
Secondary	Performance of the algorithm	Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)	Day 1
Secondary	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
Secondary	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
Secondary	Respiratory status	Weaning duration (number of days), ventilator free days and respiratory status at discharge	At Unit care discharge, an average of 14 days
Secondary	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
Secondary	Unit Care length of stay	Number of days in ICU	At Unit care discharge, an average of 14 days
Secondary	Safety of the procedure	Numbers of Serious adverse events and Material defect events	One day after Unit Care discharge, an average of 15 days