Health TrialsbyHealthPanel

Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients

ConditionsSleep Disorder (Disorder)Critical Care
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

In intensive care, sleep disturbances are extremely common and represent a major source of discomfort for patients. Restorative sleep is very limited. Beyond being the primary source of discomfort reported by patients, these sleep disturbances are associated with difficulties in weaning from mechanical ventilation, an increased risk of delirium, and potentially higher mortality. Traditional treatments artificially increase the total duration of sleep but lead to disrupted sleep architecture.

Gamma-hydroxybutyrate (GHB) is currently used for several sleep disorders, such as narcolepsy, due to its ability to increase restorative sleep. This medication has been used for years as a sedative in intensive care. Despite these potential benefits, the efficacy of GHB has never been evaluated for sleep disturbances in intensive care settings.

This study focuses on evaluating the effectiveness of intravenous Gamma-hydroxybutyrate (GHB) in the treatment of sleep disorders in intensive care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

Hospitalized in the ICU for more than 48 hours

Informed consent obtained from the patient

Disqualifiers

Unstable patient

Known allergy to Gamma-Hydroxybutyrate or any of the excipients

Technical impossibility of performing polysomnography

Childbearing or Positive pregnancy test for women of childbearing age or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • GHB

    Drug

    Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.

  • Placebo

    Drug

    Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: GHBExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Deep slow-wave sleep

The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings.

Time frame
During the night between the day of enrollment (Day0) and the next day (Day 1).

Secondary outcomes

1

Sleep onset latency

Time frame
During the night between the day of enrollment (Day0) and the next day (Day 1).
2

Total sleep time

Time frame
During the night between the day of enrollment (Day0) and the next day (Day 1).
3

Duration of N1 stage

Time frame
During the night between the day of enrollment (Day0) and the next day (Day 1).
4

Percentage of N1 stage

Time frame
During the night between the day of enrollment (Day0) and the next day (Day 1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: