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

NCT ID: NCT05963672

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2024-07-20

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")

Conditions

Sleep Quality; Critically Ill Patient; Intensive Care Unit

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Group Type: SHAM_COMPARATOR

Control condition

Intervention Type: 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.

EEG-guided sleep protection

Group Type: EXPERIMENTAL

EEG-guided sleep protection

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Poitiers

Poitiers, , France

Countries

France

Other Identifiers

SleepScan

Identifier Type: -

Identifier Source: org_study_id