Weaning from Mechanical VentilationPhase 2GO-SLEEPNCT04224246
Impact of Gamma-OH on Sleep in ICU Patients
A Phase 2 study testing Gamma Hydroxybutyrate in people with Weaning from Mechanical Ventilation, run by Poitiers University Hospital at 1 site in France.
Trial summary
The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning from Mechanical Ventilation
- What is being tested?
- Gamma Hydroxybutyrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2020to 9 Feb 2023
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intubated at least 24 hours
- difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
- Patients will be included after to obtain inform consent.
Who cannot join
- neuromuscular disease
- central nervous disease
- psychiatric disease
- severe obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean from Mechanical Ventilation
The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.
- Conditions
- Weaning from Mechanical Ventilation
- Being tested
- Gamma Hydroxybutyrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma HydroxybutyrateDrug
Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| One arm with Gamma-OH® treatment | Experimental | Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m. Receives: Drug: Gamma Hydroxybutyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having poor sleep with Gamma-OH
Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.
Measured: Hour24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start27 Feb 2020
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning from Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224246
- Sponsor's protocol ID
- GO-SLEEP
- Acronym
- GO-SLEEP
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2020
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean from Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04224246
- Acronym / sponsor ID
- GO-SLEEP / GO-SLEEP
- Conditions
- Weaning from Mechanical Ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- 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.
The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm with Gamma-OH® treatment | Experimental | Drug: Gamma HydroxybutyrateGamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- intubated at least 24 hours
- difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
- Patients will be included after to obtain inform consent.
Key exclusion criteria (4 listed)
- neuromuscular disease
- central nervous disease
- psychiatric disease
- severe obesity
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 |
|---|---|---|
| Gamma HydroxybutyrateGamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours | Drug | One arm with Gamma-OH® treatment |
Primary outcome
Proportion of patients having poor sleep with Gamma-OH
Time frame: Hour24
Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gamma Hydroxybutyrate in people with Weaning from Mechanical Ventilation, run by Poitiers University Hospital at 1 site in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Feb 2025. 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 France. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients having poor sleep with Gamma-OH (time frame: Hour24). 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 20 Feb 2025.