Usage of Baclofen for Sleep Improvement After Cardiac Surgery

• Sponsor: University of Liege (Other)
• Overall Status: Suspended
• CT.gov ID: NCT02529514
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep	Drug: Baclofen; Drug: Placebo	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Usage of Baclofen for Sleep Improvement After Cardiac Surgery
• Study Start Date: Jul 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Baclofen Baclofen 25 mg per os for 7 days at 10 pm every day	Drug: Baclofen; 25 mg for 7 days at 10 pm every day
Placebo Comparator: Placebo Placebo per os for 7 days at 10 pm every day	Drug: Placebo; Placebo for 7 days at 10 pm every day

Outcome Measures

Primary Outcome Measures

1. Polysomnography (quantity & quality of sleep) [Participants will be followed for the duration of hospital stay, an expected average of 10 days]

   Sleep assessment by polysomnography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Liège	Liège		Belgium	4000

Sponsors and Collaborators

• University of Liege

Investigators

• Study Director: Pierre Damas, Professor, Soins intensifs généraux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Damien Wertz, MD, University of Liege
• ClinicalTrials.gov Identifier: NCT02529514
• Other Study ID Numbers: Baclo-Sleep
• First Posted: Aug 20, 2015
• Last Update Posted: May 13, 2016
• Last Verified: May 1, 2016

• Keywords provided by Damien Wertz, MD, University of Liege: Baclofen; Cardiac Surgery; Polysomnography; Intensive Care Units; Sleep
• Additional relevant MeSH terms: Baclofen

Study Results

No Results Posted as of May 13, 2016