Improving sleep in Intensive Care

Phase 2

• Conditions: Sleep deprivation; ICU delirium; Critical illness; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12620000661976
• Lead Sponsor: niversity of Queensland

Brief Summary

Research question: Does a "good quality" sleep, reduce the incidence of ICU related delirium? Background: Despite all the studies conducted to date, exogenous administration of melatonin in critically ill patients has shown to significantly increase plasma levels of melatonin. This study aims to demonstrate a correlation between plasma levels of melatonin, an improvement on the sleep architecture or a reduction in ICU related delirium. Participant characteristics: A sample of critically ill patients in the recovery phase of their disease were consecutively recruited to a double-blind placebo-controlled trial of 6 mg enteral melatonin versus placebo via a nasogastric feeding tube. Inclusion criteria included: patients expected to have a minimal length of 5 days of respiratory weaning, vasopressor free and with preserved absorption (defined as aspirates lesser than 400 ml 4th hourly), absence of ileus and discontinuation of sedation. Key results: Baseline delirium and agitation scores showed no statistical difference between groups when compared to post-intervention scores. Sleep studies were comparable between both groups. The arousal index (number of arousals per hour of sleep) post-intervention was not statistically different when compared to placebo or baseline. Limitations: Slow recruitment leading to an earlier termination

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-08-26
• Study Start: 2020-06-09
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

* Ventilated patients in their weaning phase
* Integrity of the enteral system (capacity to absorb enteral medication)

All patients will be ICU inpatients

Exclusion Criteria

-- Patients with an inflammatory response
-- Septic patients
-- Burns
-- Patients on vasopressors
-- Patients with underlying psychiatric disorders on baseline antipsychotic medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure:<br>1) number of Sleep arousal<br>By utilising the gold standard for sleep recording: polysomnogram[Primary outcome measure on the last day of the intervention (day 5 of intervention)<br>This will be a second and last polysomnogram recording which will be done on the last day of drug / placebo];2) length of sleep REM phase<br>Utilising the gold standard measure for sleep assessment: polysomnogram[Same timepoint than for first outcome measure, day 5 of recruitment]

Secondary Outcome Measures

Name	Time	Method
Change in ICU related delirium assessed by applying the CAM and RASS scales which are the validated scales for Delirium and Agitation in Critical care<br><br><br>[Measured at the end of the intervention (day 5 after initiating melatonin / placebo)]