Sleep Quantity and Quality in the ICU: a Prospective Observational Study

Careggi Hospital1 site in 1 country72 target enrollmentFebruary 1, 2018

ConditionsSleep Disturbance Critical Illness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Disturbance
Sponsor: Careggi Hospital
Enrollment: 72
Locations: 1
Primary Endpoint: Sleep N2 phase
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2018

End Date

March 31, 2019

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Careggi Hospital

Responsible Party

Principal Investigator

Gianluca Villa

M.D.

Careggi Hospital

Eligibility Criteria

Inclusion Criteria

•age \> 18 years

Exclusion Criteria

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

Outcomes

Primary Outcomes

Sleep N2 phase

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

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

Secondary Outcomes

Sleep N1 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)
Sleep N3 phase(The sleep architecture will be observed during the first night spent in the ICU)