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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03796338
Enrollment
72
Registered
2019-01-08
Start date
2018-02-01
Completion date
2019-03-31
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Sleep Disturbance

Keywords

intensive care unit, Sleep interruption, Sleep phases

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.

Interventions

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.

Sponsors

Careggi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* age \> 18 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep N2 phaseThe sleep architecture will be observed during the first night spent in the ICUdescribe the percentage of the total sleep time spent by the patient in N2 stage

Secondary

MeasureTime frameDescription
Sleep N3 phaseThe sleep architecture will be observed during the first night spent in the ICUdescribe the percentage of the total sleep time spent by the patient in N3 stage
Sleep N1 phaseThe sleep architecture will be observed during the first night spent in the ICUdescribe the percentage of the total sleep time spent by the patient in N1 stage
Sleep REM phaseThe sleep architecture will be observed during the first night spent in the ICUdescribe the percentage of the total sleep time spent by the patient in REM stage

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026