A Phase 4 interventional study of Baclofen and Placebo in Sleep, sponsored by University of Liege. Suspended at 1 site in Belgium. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by University of Liege · Phase 4, Interventional, and Treatment
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.
This is a prospective randomized single-blind study involving patients adults admitted to the University Hospital of Liege for a scheduled heart surgery.
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.
University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Baclofen 25 mg per os for 7 days at 10 pm every day
Drug: Baclofen
Placebo per os for 7 days at 10 pm every day
Drug: Placebo
25 mg for 7 days at 10 pm every day
Placebo for 7 days at 10 pm every day
Polysomnography (quantity & quality of sleep)
Sleep assessment by polysomnography
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
This study is suspended, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of Liege