Electrophysiological analysis of Gamma-Hydroxybutyrate-induced sleep in intensive care patients: A Pilot Double-Blind Randomized Controlled Trial.(GAMMA-SLEEP)

Conditions

as sleep disorders affect all ICU patients after 48 hours., The study population includes adult ICU patients with a hospitalization of more than 48 hours. We have chosen to include patients with or without mechanical ventilation

Brief summary

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

Detailed description

1) Quantity and quality of nocturnal sleep. •Sleep onset latency • Total sleep time •Duration and percentage of N1 stage (sleep onset). • Duration and percentage of N2 stage (light slow-wave sleep). • Percentage of N3 stage (deep slow-wave sleep). • Duration and percentage of Rapid Eye Movement sleep (REM). • Quantification of intra-sleep wakefulness. • Quantification of atypical sleep. •Quantification of pathological wakefulness •Quantification of micro-awakenings. • Sleep efficiency, Quality of daytime alertness: • Daytime vigilance score (Karolinska Sleepiness scale) • Average sleep latency during the Maintenance of Wakefulness Test (MWT) the morning after the study night, Analgesic consumption and participation in rehabilitation: •Morphine equivalent quantification •Assessment of rehabilitation participation, Evaluation of adverse events, particularly hypokalemia, hypernatremia, mental confusion, agitation, arterial hypertension, or bradycardia

Related papers

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Interventions

DRUGNaCl 0.9%

DRUGGAMMA-OH 200 mg/ml

DRUGsolution injectable (IV)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
1) Quantity and quality of nocturnal sleep. •Sleep onset latency • Total sleep time •Duration and percentage of N1 stage (sleep onset). • Duration and percentage of N2 stage (light slow-wave sleep). • Percentage of N3 stage (deep slow-wave sleep). • Duration and percentage of Rapid Eye Movement sleep (REM). • Quantification of intra-sleep wakefulness. • Quantification of atypical sleep. •Quantification of pathological wakefulness •Quantification of micro-awakenings. • Sleep efficiency, Quality of daytime alertness: • Daytime vigilance score (Karolinska Sleepiness scale) • Average sleep latency during the Maintenance of Wakefulness Test (MWT) the morning after the study night, Analgesic consumption and participation in rehabilitation: •Morphine equivalent quantification •Assessment of rehabilitation participation, Evaluation of adverse events, particularly hypokalemia, hypernatremia, mental confusion, agitation, arterial hypertension, or bradycardia	—

Measure

Time frame

1) Quantity and quality of nocturnal sleep. •Sleep onset latency • Total sleep time •Duration and percentage of N1 stage (sleep onset). • Duration and percentage of N2 stage (light slow-wave sleep). • Percentage of N3 stage (deep slow-wave sleep). • Duration and percentage of Rapid Eye Movement sleep (REM). • Quantification of intra-sleep wakefulness. • Quantification of atypical sleep. •Quantification of pathological wakefulness •Quantification of micro-awakenings. • Sleep efficiency, Quality of daytime alertness: • Daytime vigilance score (Karolinska Sleepiness scale) • Average sleep latency during the Maintenance of Wakefulness Test (MWT) the morning after the study night, Analgesic consumption and participation in rehabilitation: •Morphine equivalent quantification •Assessment of rehabilitation participation, Evaluation of adverse events, particularly hypokalemia, hypernatremia, mental confusion, agitation, arterial hypertension, or bradycardia

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Outcome results

None listed