Usage of Baclofen for Sleep Improvement After Cardiac Sur... | NCT02529514

Studies
Usage of Baclofen for Sleep Improvement After Cardiac Surgery

NCT02529514

Sponsor

University of Liege

Status

Suspended

Last Update Posted

May 13, 2016Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Sleep

Interventions

Baclofen
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Jun 4, 2015

First Submission Date that Met QC Criteria

Aug 18, 2015

First Posted Date

Aug 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baclofen	Active Comparator	Baclofen 25 mg per os for 7 days at 10 pm every day	Drug: Baclofen
Placebo	Placebo Comparator	Placebo per os for 7 days at 10 pm every day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baclofen	Drug	25 mg for 7 days at 10 pm every day	Baclofen
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Damas, Professor	Soins intensifs généraux	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Liège		Liège	Liège	4000	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D001418	Baclofen

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

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Browse Branches

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