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

NCT ID: NCT03796338

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disturbance Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill patients

age \> 18 years

Sleep Profiler

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Careggi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Villa

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Villa, MD

Role: STUDY_DIRECTOR

Azienda Careggi

Locations

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Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CEAVC, 8611/2018; 11535/OSS

Identifier Type: -

Identifier Source: org_study_id

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