Using melatonin to improve sleep in ICU patients

Exogenous Melatonin in Intensive Care Unit Chronodisruption: Randomized Controled Trial

This study is testing if giving melatonin can help improve sleep for patients in the ICU and make their recovery easier.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Saint-Joseph University (other)
• Locations: 1 site (Beirut)
• Trial ID: NCT03708341 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of melatonin on sleep quality and duration in patients in intensive care units (ICUs). It aims to evaluate whether administering melatonin can reduce sleep deprivation and confusion associated with ICU stays, particularly in a larger population than previously studied. The study will also explore the relationship between genetic factors and the response to melatonin treatment. Participants will receive either melatonin or a placebo while their sleep patterns and overall well-being are monitored.

Who should consider this trial

Good fit: Ideal candidates are patients over 18 years old who are expected to stay in the ICU for more than 48 hours.

Not a fit: Patients with pre-existing severe sleep disorders or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve sleep quality and reduce confusion in ICU patients, enhancing their recovery process.

How similar studies have performed: While there have been limited studies on melatonin in ICU settings, this approach is novel as it aims to assess a larger population and genetic factors influencing treatment response.

Eligibility criteria

Inclusion Criteria:

* Patients or their parents who have signed an informed consent allowing us to exploit and analyse their clinical, biological and pharmacological data (see Appendix 1)
* Patients staying more than 48 hours in ICU (acute ICU confusion occurs in the 48-72h following admission)
* Drugs affecting sleep architecture (co-variables):

  * Opiates: increase N2, decrease REM
  * NSAIDs: reduce sleep efficacy, increase arousal
  * Beta blockers: insomnia, REM sleep disappearance
  * Corticosteroids (varies according to half life and dose): REM sleep disappearance, induce awakening, stimulant effect
  * Haloperidol: increases sleep efficacy, increases N2 duration
* Respiratory assistance: ventilated patients v/s non ventilated patients (co-variables)
* Patients presenting with delirium or sleep disorders at admission will not be excluded, but a note will be taken on the baseline case report form (CRF)

Exclusion Criteria:

* Patients less than 18 years old
* Patients with central neurological disease: post traumatic patients, Parkinson disease, patients presenting with CVA, patients with neurodegenerative diseases, etc.
* Patients taking drugs capable of altering or inducing delirium:

  * Atypical antipsychotics (olanzapine, risperidone, etc.), which increase sleep efficacy, total sleep time, and NREM sleep, and reduce prevalence of ICU psychosis
  * BZD-like drugs (zolpidem, zopiclone) which induce delirium
* Melatonin allergy
* Any disorders capable of altering oral melatonin absorption (e.g. intestinal occlusion)
* Predicted ICU stay of less than 24 hours (e.g. post surgical monitoring)

Where this trial is running

Beirut

• Hotel Dieu de France — Beirut, Lebanon (RECRUITING)

Study contacts

• Study coordinator: Moussa A Riachy, MD

Conditions: Sleep Deprivation, Intensive Care Psychosis, melatonin