Respiratory FailureREVASOMNCT07522450
Benefit of Sleep Quality Monitoring by EEG in ICU
An observational study of Respiratory Failure, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- EEG monitoring
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2026to 20 Mar 2027
- Phase
- Observational
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
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.
Who may be able to join
- Adults
- Acute respiratory failure with non-invasive ventilation or high-flow oxygenotherapy hospitalized in critical care unit
- Conscious
- Insurance coverage
- Consent to participate
Who cannot join
- pregnancy
- cutaneous lesion on the scalp
- guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de ROUEN
Rouen, 76 031
MArie-Anne MELONE, MD, marieanne.melone@chu-rouen.fr
About this study
Official title: 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.
- Conditions
- Respiratory Failure
- Being tested
- EEG monitoring
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringOther
Participants will have their sleep quality assessed by both EEG monitoring and nurse evaluation during their stay in critical care unit.
| Study group | Role | What they receive |
|---|---|---|
| Adults hospitalized in critical care for acute respiratory failure | Not described Receives: Other: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep stage
wake-sleep state mesured by both EEG montoring and nurse assessment
Measured: through study completion, an average of 7 days
Secondary outcomes (4)
total sleep time
measured by EEG monitoring
Measured: periprocedurally
sleep quality
mesured by richards-campbell sleep questionnaire
Measured: through study completion, an average of 7 days
anxiety
measured by HAD
Measured: through study completion, an average of 7 days
respiratory assessment
arterial blod gases
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start4 Mar 2026
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522450
- Sponsor's protocol ID
- 2025/0321/HP
- Acronym
- REVASOM
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No