Benefit of Sleep Quality Monitoring by EEG in ICU (REVASOM)

May 12, 2026 updated by: University Hospital, Rouen

Benefit of the Sleep Quality Assessment Using Electroencephalographic Monitoring in Critically Ill Patients

The goal of this observational study is to learn about the benefit of monitoring sleep quality using EEG in patients hospitalized in critical care unit for acute respiratory failure. The main question it aims to answer is:

• Does EEG monitoring improve sleep quality assessment in critically ill patients with acute respiratory failure compared to nurse sleep quality assessment? Participants hospitalized in critical care unit for acute respiratory failure will have their sleep quality assessed by both EEG monitoring and nurse evaluation during their stay in critical care unit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

During their stay in cricital care unit, patients with acute respiratory failure and ventilatory assistance by non-invasive ventilation and/or hig-flow oxygen therapy will included if all criteria are met. Participants will have their sleep quality assessed by both EEG monitoring and nurse assessment during the nights in critical care unit. Variables such as demographics, comorbidities, history of the disease leading to critical care unit, respiratory assessment, anxiety depression scale, sleep quality scale will be monitored.

Description

Inclusion Criteria:

  • Adults
  • Acute respiratory failure with non-invasive ventilation or high-flow oxygenotherapy hospitalized in critical care unit
  • Conscious
  • Insurance coverage
  • Consent to participate

Exclusion Criteria:

  • pregnancy
  • cutaneous lesion on the scalp
  • guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults hospitalized in critical care for acute respiratory failure
Other: EEG monitoring
Participants will have their sleep quality assessed by both EEG monitoring and nurse evaluation during their stay in critical care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep stage
Time Frame: through study completion, an average of 7 days
wake-sleep state mesured by both EEG montoring and nurse assessment
through study completion, an average of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total sleep time
Time Frame: periprocedurally
measured by EEG monitoring
periprocedurally
sleep quality
Time Frame: through study completion, an average of 7 days
mesured by richards-campbell sleep questionnaire
through study completion, an average of 7 days
anxiety
Time Frame: through study completion, an average of 7 days
measured by HAD
through study completion, an average of 7 days
respiratory assessment
Time Frame: through study completion, an average of 7 days
arterial blod gases
through study completion, an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

March 20, 2027

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/0321/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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