Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit (SleepScan)
Primary Purpose
Sleep Quality, Critically Ill Patient, Intensive Care Unit
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG-guided sleep protection
Control condition
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Quality
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Usual Care
EEG-guided sleep protection
Arm Description
Outcomes
Primary Outcome Measures
Sleep quality
Proportion of continuous sleep
Secondary Outcome Measures
Sleep fragmentation
Number of arousals and awakenings per hour of sleep
Environmental noise and environmental light
Number of peak noise end time spent above 20 lux
Sleep interruptions by caregivers
Number of room entries while patient is asleep
Sleep quality
Proportion of continuous sleep
Workload assessed by nurses
Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.
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)
Performance of the algorithm
Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)
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
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.
Respiratory status
Weaning duration (number of days), ventilator free days and respiratory status at discharge
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.
Unit Care length of stay
Number of days in ICU
Safety of the procedure
Numbers of Serious adverse events and Material defect events
Full Information
NCT ID
NCT05963672
First Posted
June 19, 2023
Last Updated
July 28, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05963672
Brief Title
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit
Acronym
SleepScan
Official Title
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 25, 2023 (Anticipated)
Primary Completion Date
August 23, 2024 (Anticipated)
Study Completion Date
August 27, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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")
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Critically Ill Patient, Intensive Care Unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Title
EEG-guided sleep protection
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
EEG-guided sleep protection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep quality
Description
Proportion of continuous sleep
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Sleep fragmentation
Description
Number of arousals and awakenings per hour of sleep
Time Frame
Day 1
Title
Environmental noise and environmental light
Description
Number of peak noise end time spent above 20 lux
Time Frame
Day 1 to Day 4
Title
Sleep interruptions by caregivers
Description
Number of room entries while patient is asleep
Time Frame
Day 1 to Day 4
Title
Sleep quality
Description
Proportion of continuous sleep
Time Frame
Day 2 to Day 4
Title
Workload assessed by nurses
Description
Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.
Time Frame
Day 1 to Day 4
Title
Patient Agitation
Description
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)
Time Frame
Day 1 to day 4
Title
Performance of the algorithm
Description
Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)
Time Frame
Day 1
Title
Patient reported sleep quality
Description
Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep
Time Frame
Day 1 to day 4
Title
Anxiety level
Description
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.
Time Frame
Day 1 to day 4
Title
Respiratory status
Description
Weaning duration (number of days), ventilator free days and respiratory status at discharge
Time Frame
At Unit care discharge, an average of 14 days
Title
Presence of delirium
Description
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.
Time Frame
Day 1 to Day 4
Title
Unit Care length of stay
Description
Number of days in ICU
Time Frame
At Unit care discharge, an average of 14 days
Title
Safety of the procedure
Description
Numbers of Serious adverse events and Material defect events
Time Frame
One day after Unit Care discharge, an average of 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier DROUOT, Pr
Phone
05 49 44 34 65
Ext
+33
Email
xavier.drouot@chu-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit
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