Sleep DisordersNCT00507481
Evaluation of Risk Factors of Sleep Quality in Intensive Care Unit
An observational study of Sleep Disorders and Delirium, run by University of Turin, Italy at 2 sites in Italy.
Trial summary
The aim of this study was to investigate the relationship between sleep disturbances and delirium in surgical ICU patients. The study set up to test the hypothesis that the occurrence of delirium is associated to the alteration of sleep quality and quantity observed in the critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disorders, Delirium
- How many people
- Not given
- Where
- 2 sitesItaly
- Study dates
- Jan 2006to Sep 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU
Who may be able to join
- Adult, postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU
Who cannot join
- Defined a priori
- Were history of chronic dementia, psychosis, mental retardation, stroke syndrome or other primary neurologic disease
- Patient refusal to participate
- Alcohol and drug abuse.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Intensive care Unit S.giovanni Battista Hospital
Turin, Turin, 10126
ICU University S.G.Battista Hospital
Turin, 10126
About this study
Official title: Evaluation of Risk Factors of Sleep Quality in Critically Ill Patients
The aim of this study was to investigate the relationship between sleep disturbances and delirium in surgical ICU patients. The study set up to test the hypothesis that the occurrence of delirium is associated to the alteration of sleep quality and quantity observed in the critically ill patients.
Read the detailed description
Sleep disorders are an important clinical entity affecting outcome in respiratory, cardiovascular, metabolic and psychiatric disorders and exacting a potentially significant toll on patients at both a personal and socio-economic level.Delirium is a common organ dysfunction in the critically ill patients characterized by an acute onset of impaired cognitive function [REF] associated with prolonged ICU and hospital stay, nosocomial pneumonia, and death.
- Conditions
- Sleep Disorders, Delirium
- Keywords
- Sleep, ICU, Delirium, Post surgical ventilated patients, ICU patients
- Medical subject headings
- Sleep Wake Disorders, Delirium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startJan 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Marco V Ranieri, Professor, Study director, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507481
- Sponsor's protocol ID
- 4627
- Status last verified
- Jun 2008
- First submitted
- 24 Jul 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Risk Factors of Sleep Quality in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00507481
- Acronym / sponsor ID
- 4627
- Conditions
- Sleep Disorders, Delirium
- Keywords
- Sleep, ICU, Delirium, Post surgical ventilated patients, ICU patients
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Jul 2007 (estimated)
- 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.
The aim of this study was to investigate the relationship between sleep disturbances and delirium in surgical ICU patients. The study set up to test the hypothesis that the occurrence of delirium is associated to the alteration of sleep quality and quantity observed in the critically ill patients.
Detailed description
Sleep disorders are an important clinical entity affecting outcome in respiratory, cardiovascular, metabolic and psychiatric disorders and exacting a potentially significant toll on patients at both a personal and socio-economic level.Delirium is a common organ dysfunction in the critically ill patients characterized by an acute onset of impaired cognitive function [REF] associated with prolonged ICU and hospital stay, nosocomial pneumonia, and death.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU
Key inclusion criteria (1 listed)
- Adult, postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU
Key exclusion criteria (4 listed)
- Defined a priori
- Were history of chronic dementia, psychosis, mental retardation, stroke syndrome or other primary neurologic disease
- Patient refusal to participate
- Alcohol and drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Jun 2008.
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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.
Marco V Ranieri, Professor study director
University of Turin, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders and Delirium, run by University of Turin, Italy at 2 sites 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 4 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 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 4 Jun 2008.