Usage of Baclofen for Sleep Improvement After Cardiac Surgery

May 11, 2016 updated by: Damien Wertz, University of Liege
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography (quantity & quality of sleep)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Sleep assessment by polysomnography
Participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baclo-Sleep

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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