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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796338
• Other study ID #: CEAVC, 8611/2018; 11535/OSS
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2022
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• age > 18 years

Exclusion Criteria:

• Pregnancy

• Previous enrollment in the same study (sleep recording during previous night)

• Previous use of hypnotic drugs

Related Conditions & MeSH terms

• Critical Illness
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep N2 phase	describe the percentage of the total sleep time spent by the patient in N2 stage	The sleep architecture will be observed during the first night spent in the ICU
Secondary	Sleep N1 phase	describe the percentage of the total sleep time spent by the patient in N1 stage	The sleep architecture will be observed during the first night spent in the ICU
Secondary	Sleep N3 phase	describe the percentage of the total sleep time spent by the patient in N3 stage	The sleep architecture will be observed during the first night spent in the ICU
Secondary	Sleep REM phase	describe the percentage of the total sleep time spent by the patient in REM stage	The sleep architecture will be observed during the first night spent in the ICU