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

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.

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Key information

Conditions

Sleep Disturbance Critical Illness Disease Attributes Mental Disorders Nervous System Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

age > 18 years

Exclusion criteria

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

Treatment and study plan

Sleep Profiler

Device

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.

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

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 N1 stage
Sleep N3 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 N3 stage
Sleep REM 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 REM stage

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 8, 2019
Registry last updated: Jul 22, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed