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

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ClinicalTrials.gov Identifier: NCT03796338
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluca Villa, Careggi Hospital

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.


Condition or disease Intervention/treatment
Sleep Disturbance Critical Illness Device: Sleep Profiler

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Quantity and Quality in the ICU: a Prospective Observational Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 31, 2019

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796338


Contacts
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Contact: Silvia Benemei, MD +390557946999 silvia.benemei@unifi.it
Contact: Gianluca Villa +393207615547 gianluca.villa@unifi.it

Locations
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Italy
Azienda Ospedaliero Universitaria Careggi Recruiting
Florence, Italy, 50100
Contact: Gianluca Villa, MD    +393207615547    gianluca.villa@unifi.it   
Principal Investigator: Stefano Romagnoli, MD, PhD         
Sponsors and Collaborators
Careggi Hospital
Investigators
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Study Director: Gianluca Villa, MD Azienda Careggi

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Responsible Party: Gianluca Villa, M.D., Careggi Hospital
ClinicalTrials.gov Identifier: NCT03796338     History of Changes
Other Study ID Numbers: CEAVC, 8611/2018; 11535/OSS
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Gianluca Villa, Careggi Hospital:
intensive care unit
Sleep interruption
Sleep phases
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Critical Illness
Disease Attributes
Pathologic Processes
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms