Impact of Gamma-OH on Sleep in ICU Patients

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.

Completed

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Key information

Conditions

Weaning From Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gamma Hydroxybutyrate

Drug

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

Primary outcomes

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®.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: GO-SLEEP

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jan 13, 2020
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed