Usage of Baclofen for Sleep Improvement After Cardiac Surgery
NCT ID: NCT02529514
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
30 participants
INTERVENTIONAL
2015-07-31
2016-06-30
Brief Summary
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Detailed Description
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The study is based on the oral administration of baclofen (or placebo) the evening Bedrooms (10 pm). This administration begins the day before surgery and ends 5th day after. Sleep is evaluated by various questionnaires at baseline, during the protocol and the end. In addition, a 24 polysomnography is performed the day after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Baclofen
Baclofen 25 mg per os for 7 days at 10 pm every day
Baclofen
25 mg for 7 days at 10 pm every day
Placebo
Placebo per os for 7 days at 10 pm every day
Placebo
Placebo for 7 days at 10 pm every day
Interventions
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Baclofen
25 mg for 7 days at 10 pm every day
Placebo
Placebo for 7 days at 10 pm every day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Epilepsy
* Psychotic disturbances
* Acute / Chronic respiratory failure
* Morbid obesity (BMI \> 45 kg/m2)
* Sleep apnea (treated)
* Severe hepatic or renal failure
* Patient refusal
60 Years
ALL
No
Sponsors
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University of Liege
OTHER
Responsible Party
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Damien Wertz
MD
Principal Investigators
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Pierre Damas, Professor
Role: STUDY_DIRECTOR
Soins intensifs généraux
Locations
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Centre Hospitalier Universitaire de Liège
Liège, Liège, Belgium
Countries
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Other Identifiers
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Baclo-Sleep
Identifier Type: -
Identifier Source: org_study_id
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