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Exogenous Melatonin in Intensive Care Unit Chronodisruption

NCT03708341 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-02-14

No results posted yet for this study

Summary

To this day, a small number of studies have evaluated the effect of melatonin on the modifications of the characteristics of sleep in critical care units, with mostly a small studied population. However, no study has been realized on a large population, nor has it evaluated the association between genetic factors and response to treatment (melatonin), hence the originality of our study. In our study we hypothesized that systematic melatonin usage in ICU can ameliorate the total sleep time and the fragmentation index and can decrease the confusion related to sleep deprivation.

Conditions

  • Sleep Deprivation
  • Intensive Care Psychosis

Interventions

DRUG

Melatonin 5 mg

Systematic daily administration of melatonin 5 mg during patient's ICU stay

DRUG

Placebo Oral Tablet

Systematic daily administration of placebo during patient's ICU stay

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708341 on ClinicalTrials.gov