Status:
COMPLETED
Improving Sleep Quality in ICU Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Intensive Care Unit Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable co...
Detailed Description
It is well demonstrated that sleep architecture is deeply altered in intensive care unit (ICU patients). The consequences of this alteration are multiple: neuropsychological complication such as delir...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Admission in the ICU with expected duration of stay \> 48hrs.
- Level of sedation \< 4 on Ramsay scale.
- Interruption of sedation \> 12 hrs
- Analgesia with a maximal dose of morphine \< 0.01 mg/Kg/h
- Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.
- Informed consent by patients or next of kind.
- Exclusion criteria :
- Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).
- Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.
- Severe liver encephalopathy (stage 3 or 4)
- Ongoing sepsis
- Pregnancy.
- Age \< 18 yrs.
- No health insurance.
Exclusion
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02292134
Start Date
July 1 2012
End Date
December 1 2013
Last Update
November 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6
Paris, France, 75013