Sleep QualitySleepScanNCT05963672
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit
A study testing EEG-guided sleep protection in people with Sleep Quality and Critically Ill Patient, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Critically Ill Patient, Intensive Care Unit
- What is being tested?
- EEG-guided sleep protection
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2023to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)
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.
Read more
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
- Being tested
- EEG-guided sleep protection, Control condition
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-guided sleep protectionDevice
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 conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Sham comparator | Not described Receives: Other: Control condition |
| EEG-guided sleep protection | Experimental | Not described Receives: Device: EEG-guided sleep protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Proportion of continuous sleep
Measured: Day 1 to Day 4
Secondary outcomes (14)
Sleep fragmentation
Number of awakenings and micro-awakenings per hour of sleep
Measured: Day 1 to Day 4
Environmental noise and environmental light
Number of peak noise end time spent above 20 lux
Measured: Day 1 to Day 4
Sleep interruptions by caregivers
Number of room entries while patient is asleep
Measured: Day 1 to Day 4
Sleep quality
Proportion of continuous sleep
Measured: Day 2 to Day 4
Workload assessed by nurses
Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.
Measured: Day 1 to Day 4
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)
Measured: Day 1 to day 4
Performance of the algorithm
Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)
Measured: Day 1 to Day 4
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
Measured: Day 1 to day 4
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.
Measured: Day 1 to day 4
Respiratory status
Weaning duration (number of days), ventilator free days and respiratory status at discharge
Measured: At Unit care discharge, an average of 14 days
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.
Measured: Day 1 to Day 4
Unit Care length of stay
Number of days in ICU
Measured: At Unit care discharge, an average of 14 days
Safety of the procedure
Numbers of Serious adverse events and Material defect events
Measured: One day after Unit Care discharge, an average of 15 days
Sleep continuity
Part of sleep time past in more than 10 minutes episodes
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start8 Aug 2023
- Primary completion14 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963672
- Sponsor's protocol ID
- SleepScan
- Acronym
- SleepScan
- Status last verified
- Sep 2024
- First submitted
- 19 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)
- ClinicalTrials.gov ID
- NCT05963672
- Acronym / sponsor ID
- SleepScan / SleepScan
- Conditions
- Sleep Quality, Critically Ill Patient, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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")
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Sham comparator | Other: Control condition |
| EEG-guided sleep protection | Experimental | Device: EEG-guided sleep protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults admitted in medical ICU of University Hospital of Poitiers
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-guided sleep protectionThe 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. | Device | EEG-guided sleep protection |
| Control conditionthe 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. | Other | Usual Care |
Primary outcome
Sleep quality
Time frame: Day 1 to Day 4
Proportion of continuous sleep
14 secondary outcomes
Sleep fragmentation
Time frame: Day 1 to Day 4
Environmental noise and environmental light
Time frame: Day 1 to Day 4
Sleep interruptions by caregivers
Time frame: Day 1 to Day 4
Sleep quality
Time frame: Day 2 to Day 4
Workload assessed by nurses
Time frame: Day 1 to Day 4
Patient Agitation
Time frame: Day 1 to day 4
Performance of the algorithm
Time frame: Day 1 to Day 4
Patient reported sleep quality
Time frame: Day 1 to day 4
Anxiety level
Time frame: Day 1 to day 4
Respiratory status
Time frame: At Unit care discharge, an average of 14 days
Presence of delirium
Time frame: Day 1 to Day 4
Unit Care length of stay
Time frame: At Unit care discharge, an average of 14 days
Safety of the procedure
Time frame: One day after Unit Care discharge, an average of 15 days
Sleep continuity
Time frame: Day 1 to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Sleep Quality
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-guided sleep protection in people with Sleep Quality and Critically Ill Patient, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Day 1 to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.