NCT03796338

Brief Summary

Several evidences in the literature suggest sleep interruption in critical care patients. Nowadays, the amount and the quality of sleep phases during the length of stay in the intensive care unit are largely unknown. In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during sleep is quantified.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

January 4, 2019

Last Update Submit

July 21, 2022

Conditions

Sleep DisturbanceCritical Illness

Keywords

intensive care unitSleep interruptionSleep phases

Outcome Measures

Primary Outcomes (1)

  • Sleep N2 phase

    describe the percentage of the total sleep time spent by the patient in N2 stage

    The sleep architecture will be observed during the first night spent in the ICU

Secondary Outcomes (3)

  • Sleep N1 phase

    The sleep architecture will be observed during the first night spent in the ICU

  • Sleep N3 phase

    The sleep architecture will be observed during the first night spent in the ICU

  • Sleep REM phase

    The sleep architecture will be observed during the first night spent in the ICU

Study Arms (1)

Critically ill patients

age \> 18 years

Device: Sleep Profiler

Interventions

Sleep ProfilerDEVICE

Patients are observed through a Sleep profiler, routinely used in the intensive care unit (ICU). This device is applied at every patient in the ICU and it acquires EEG, electrooculography, and electromyography from three frontopolar EEG signals.

Critically ill patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients

You may qualify if:

  • age \> 18 years

You may not qualify if:

  • Pregnancy
  • Previous enrollment in the same study (sleep recording during previous night)
  • Previous use of hypnotic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Location

MeSH Terms

Conditions

ParasomniasCritical Illness

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gianluca Villa, MD

    Azienda Careggi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 8, 2019

Study Start

February 1, 2018

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)