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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Sleep Disturbance
• Intervention / Treatment: Device: Sleep Profiler

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50100
    • Azienda Ospedaliero Universitaria Careggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients

Description

Inclusion Criteria:

• age > 18 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients; age > 18 years	Device: Sleep Profiler; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep N1 phase	describe the percentage of the total sleep time spent by the patient in N1 stage	The sleep architecture will be observed during the first night spent in the ICU
Sleep N3 phase	describe the percentage of the total sleep time spent by the patient in N3 stage	The sleep architecture will be observed during the first night spent in the ICU
Sleep REM phase	describe the percentage of the total sleep time spent by the patient in REM stage	The sleep architecture will be observed during the first night spent in the ICU

Collaborators and Investigators

• Sponsor: Careggi Hospital
• Investigators: Study Director: Gianluca Villa, MD, Azienda Careggi

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 6, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; Sleep interruption; Sleep phases
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Wake Disorders; Disease Attributes; Dyssomnias; Parasomnias; Critical Illness
• Other Study ID Numbers: CEAVC, 8611/2018; 11535/OSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes