NCT07522450

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

February 26, 2026

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • sleep stage

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

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • total sleep time

    periprocedurally

  • sleep quality

    through study completion, an average of 1 year

  • anxiety

    through study completion, an average of 1 year

  • respiratory assessment

    through study completion, an average of 1 year

Study Arms (1)

Adults hospitalized in critical care for acute respiratory failure

Other: EEG monitoring

Interventions

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

Adults hospitalized in critical care for acute respiratory failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • cutaneous lesion on the scalp
  • guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de ROUEN

Rouen, 76 031, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

April 13, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

March 20, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations