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NCT Number: NCT07522450

Benefit of Sleep Quality Monitoring by EEG in ICU

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de ROUEN

Rouen, 76 031, France

Location status: Recruiting

Location contact

MArie-Anne MELONE, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

EEG monitoring

Other

Participants will have their sleep quality assessed by both EEG monitoring and nurse evaluation during their stay in critical care unit.

Primary outcomes

  1. sleep stage

    Time frame: through study completion, an average of 7 days

    wake-sleep state mesured by both EEG montoring and nurse assessment

Secondary outcomes

  1. total sleep time

    Time frame: periprocedurally

    measured by EEG monitoring

  2. sleep quality

    Time frame: through study completion, an average of 7 days

    mesured by richards-campbell sleep questionnaire

  3. anxiety

    Time frame: through study completion, an average of 7 days

    measured by HAD

  4. respiratory assessment

    Time frame: through study completion, an average of 7 days

    arterial blod gases

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Anne Melone, MD

CONTACT

[email protected]

+33 2 32 88 89 90

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: REVASOM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
May 15, 2026

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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