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Completed

NCT Number: NCT05963672

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

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")

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Key information

Conditions

Sleep Quality Critically Ill Patient Dyssomnias Intensive Care Unit Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG-guided sleep protection

Device

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.

Control condition

Other

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 outcomes

  1. Sleep quality

    Time frame: Day 1 to Day 4

    Proportion of continuous sleep

Secondary outcomes

  1. Sleep fragmentation

    Time frame: Day 1 to Day 4

    Number of awakenings and micro-awakenings per hour of sleep

  2. Environmental noise and environmental light

    Time frame: Day 1 to Day 4

    Number of peak noise end time spent above 20 lux

  3. Sleep interruptions by caregivers

    Time frame: Day 1 to Day 4

    Number of room entries while patient is asleep

  4. Sleep quality

    Time frame: Day 2 to Day 4

    Proportion of continuous sleep

  5. Workload assessed by nurses

    Time frame: Day 1 to Day 4

    Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.

  6. Patient Agitation

    Time frame: Day 1 to day 4

    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)

  7. Performance of the algorithm

    Time frame: Day 1 to Day 4

    Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)

  8. Patient reported sleep quality

    Time frame: Day 1 to day 4

    Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep

  9. Anxiety level

    Time frame: Day 1 to day 4

    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.

  10. Respiratory status

    Time frame: At Unit care discharge, an average of 14 days

    Weaning duration (number of days), ventilator free days and respiratory status at discharge

  11. Presence of delirium

    Time frame: Day 1 to Day 4

    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.

  12. Unit Care length of stay

    Time frame: At Unit care discharge, an average of 14 days

    Number of days in ICU

  13. Safety of the procedure

    Time frame: One day after Unit Care discharge, an average of 15 days

    Numbers of Serious adverse events and Material defect events

  14. Sleep continuity

    Time frame: Day 1 to Day 4

    Part of sleep time past in more than 10 minutes episodes

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: SleepScan

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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