Sleep DisturbanceNCT03796338
Sleep Quantity and Quality in the ICU: a Prospective Observational Stud
An observational study of Sleep Disturbance and Critical Illness, run by Careggi Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Disturbance, Critical Illness
- What is being tested?
- Sleep Profiler
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- age > 18 years
Who cannot join
- Pregnancy
- Previous enrollment in the same study (sleep recording during previous night)
- Previous use of hypnotic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Quantity and Quality in the ICU: a Prospective Observational Study
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.
- Conditions
- Sleep Disturbance, Critical Illness
- Being tested
- Sleep Profiler
- Keywords
- intensive care unit, Sleep interruption, Sleep phases
- Medical subject headings
- Parasomnias, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ProfilerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | age > 18 years Receives: Device: Sleep Profiler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep N2 phase
describe the percentage of the total sleep time spent by the patient in N2 stage
Measured: The sleep architecture will be observed during the first night spent in the ICU
Secondary outcomes (3)
Sleep N1 phase
describe the percentage of the total sleep time spent by the patient in N1 stage
Measured: The sleep architecture will be observed during the first night spent in the ICU
Sleep N3 phase
describe the percentage of the total sleep time spent by the patient in N3 stage
Measured: The sleep architecture will be observed during the first night spent in the ICU
Sleep REM phase
describe the percentage of the total sleep time spent by the patient in REM stage
Measured: The sleep architecture will be observed during the first night spent in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Feb 2018
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Villa, Careggi Hospital
- Investigators
- Gianluca Villa, MD, Study director, Azienda Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796338
- Sponsor's protocol ID
- CEAVC, 8611/2018; 11535/OSS
- Status last verified
- Jul 2022
- First submitted
- 4 Jan 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quantity and Quality in the ICU: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03796338
- Acronym / sponsor ID
- CEAVC, 8611/2018; 11535/OSS
- Conditions
- Sleep Disturbance, Critical Illness
- Keywords
- intensive care unit, Sleep interruption, Sleep phases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Device: Sleep Profilerage > 18 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (1 listed)
- age > 18 years
Key exclusion criteria (3 listed)
- Pregnancy
- Previous enrollment in the same study (sleep recording during previous night)
- Previous use of hypnotic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ProfilerPatients 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. | Device | Critically ill patients |
Primary outcome
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
3 secondary outcomes
Sleep N1 phase
Time frame: The sleep architecture will be observed during the first night spent in the ICU
Sleep N3 phase
Time frame: The sleep architecture will be observed during the first night spent in the ICU
Sleep REM phase
Time frame: The sleep architecture will be observed during the first night spent in the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Villa, MD study director
Azienda Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbance and Critical Illness, run by Careggi Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep N2 phase (time frame: The sleep architecture will be observed during the first night spent in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.