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CompletedNCT03796338Updated Jul 22, 2022

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

An observational study in Sleep Disturbance and Critical Illness, sponsored by Careggi Hospital. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Careggi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Sex
All
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Study 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.

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Conditions studied

  • Sleep Disturbance
  • Critical Illness

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Keywords

  • intensive care unit
  • Sleep interruption
  • Sleep phases
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In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 72 is below the median of 140 across 814 observational studies indexed under Critical Illness.

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Lead sponsor

Careggi Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age > 18 years

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (actual)
Patient registry
No

Groups and cohorts

  • Critically ill patients

    age \> 18 years

    Device: Sleep Profiler

Interventions

  • DeviceSleep 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.

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What researchers measure

Primary outcomes

  1. Sleep N2 phase

    describe the percentage of the total sleep time spent by the patient in N2 stage

    Time frame: The sleep architecture will be observed during the first night spent in the ICU

Secondary outcomes

  1. Sleep N1 phase

    describe the percentage of the total sleep time spent by the patient in N1 stage

    Time frame: The sleep architecture will be observed during the first night spent in the ICU

  2. Sleep N3 phase

    describe the percentage of the total sleep time spent by the patient in N3 stage

    Time frame: The sleep architecture will be observed during the first night spent in the ICU

  3. Sleep REM phase

    describe the percentage of the total sleep time spent by the patient in REM stage

    Time frame: The sleep architecture will be observed during the first night spent in the ICU

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Study locations

1 site
  • Azienda Ospedaliero Universitaria Careggi
    Florence, 50100, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03796338
Lead sponsor
Careggi Hospital
Responsible party
Gianluca Villa (M.D., Careggi Hospital) — Principal investigator
First posted
Jan 8, 2019
Start date
Feb 1, 2018
Primary completion
Jan 31, 2019
Completion
Mar 31, 2019
Last update
Jul 22, 2022

Study contacts

Gianluca Villa, MD
study director · Azienda Careggi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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