Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Sleep Clinical Trial

Official title:

Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02529514
• Other study ID #: Baclo-Sleep
• Status: Suspended
• Phase: Phase 4
• First received: June 4, 2015
• Last updated: May 11, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Elective cardiac surgery

Exclusion Criteria:

• Haemodynamic instability

• Epilepsy

• Psychotic disturbances

• Acute / Chronic respiratory failure

• Morbid obesity (BMI > 45 kg/m2)

• Sleep apnea (treated)

• Severe hepatic or renal failure

• Patient refusal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep

Intervention

Drug:
• Baclofen
25 mg for 7 days at 10 pm every day
• Placebo
Placebo for 7 days at 10 pm every day

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography (quantity & quality of sleep)	Sleep assessment by polysomnography	Participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes