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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
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 19, 2023
    Last Updated
    July 28, 2023
    Sponsor
    Poitiers University Hospital
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    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

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