SleepPhase 4NCT02529514
Usage of Baclofen for Sleep Improvement After Cardiac Surgery
A Phase 4 study testing Baclofen in people with Sleep, run by University of Liege at 1 site in Belgium.
Trial summary
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.
Read the 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.
- Conditions
- Sleep
- Being tested
- Baclofen, Placebo
- Keywords
- Baclofen, Cardiac Surgery, Polysomnography, Intensive Care Units, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
25 mg for 7 days at 10 pm every day
PlaceboDrug
Placebo for 7 days at 10 pm every day
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Active comparator | Baclofen 25 mg per os for 7 days at 10 pm every day Receives: Drug: Baclofen |
| Placebo | Placebo comparator | Placebo per os for 7 days at 10 pm every day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography (quantity & quality of sleep)
Sleep assessment by polysomnography
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damien Wertz, University of Liege
- Investigators
- Pierre Damas, Professor, Study director, Soins intensifs généraux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529514
- Sponsor's protocol ID
- Baclo-Sleep
- Status last verified
- May 2016
- First submitted
- 4 Jun 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of Baclofen for Sleep Improvement After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02529514
- Acronym / sponsor ID
- Baclo-Sleep
- Conditions
- Sleep
- Keywords
- Baclofen, Cardiac Surgery, Polysomnography, Intensive Care Units, Sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Active comparator | Drug: BaclofenBaclofen 25 mg per os for 7 days at 10 pm every day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo per os for 7 days at 10 pm every day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective cardiac surgery
Key exclusion criteria (8 listed)
- Haemodynamic instability
- Epilepsy
- Psychotic disturbances
- Acute / Chronic respiratory failure
- Morbid obesity (BMI > 45 kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen25 mg for 7 days at 10 pm every day | Drug | Baclofen |
| PlaceboPlacebo for 7 days at 10 pm every day | Drug | Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Damas, Professor study director
Soins intensifs généraux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen in people with Sleep, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (quantity & quality of sleep) (time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.