Impact of Gamma-OH on Sleep in ICU Patients

Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean from Mechanical Ventilation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04224246

Acronym

GO-SLEEP

Enrollment

Registered

2020-01-13

Start date

2020-02-27

Completion date

2023-02-09

Last updated

2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weaning from Mechanical Ventilation

Brief 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.

Interventions

DRUGGamma Hydroxybutyrate

Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* neuromuscular disease * central nervous disease * psychiatric disease * severe obesity

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients having poor sleep with Gamma-OH	Hour24	Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026