Exogenous Melatonin to Improve Sleep in Critically Ill Patients
Phase 3
Recruiting
- Conditions
- Poor sleep in tracheostomised ICU patients.Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12610000008022
- Lead Sponsor
- The Alfred
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Patients 18 years and older admitted to the ICU
2. Tracheostomy for weaning of ventilation
3. Glasgow Coma Scale (GCS) equal to or greater than 12
4. Difficulty sleeping as reported by patient or medical staff - 4 or less hours of nocturnal sleep and/or 4 or more awakenings overnight
Exclusion Criteria
1. Patients on sedative infusions
2. Contraindications to enteral feeding and/or administration of medications
3. Pregnant or breast-feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method octurnal total sleep time (22:00 to 06:00) - excludes time spent asleep after sleep rescue therapy is administered.<br><br>Two objective measures of sleep duration will be used to estimate consistency of results. These measures include wrist actigraphy, and nursing assessment. Quality of sleep will be determined by the Richards-Campbell Sleep Questionnaire (RCSQ).[22:00 to 06:00 during 7 nights of treatment regimen.]
- Secondary Outcome Measures
Name Time Method Diurnal total sleep time (06:00 to 22:00).<br><br>Two objective measures of sleep duration will be used to estimate consistency of results. These measures include wrist actigraphy, and nursing assessment.[During 7 days of treatment regimen];Number of awakenings during nocturnal sleep.<br><br>Two objective measures of nocturnal awakenings will be used to estimate consistency of results. These measures include wrist actigraphy, and nursing assessment.[During 7 days of treatment regimen.];Episodes of agitation.<br><br>The Motor Activity Assessment Scale (MAAS) is routinely used in The Alfred ICU for assessment of sedation and agitation. The MAAS is located on the back of the ICU observation chart and patient's MAAS scores are documented hourly on the front of the observation chart by nursing staff. A MAAS score of 5 or more indicates agitation.[During 7 days of treatment regimen.];Length of stay in ICU.<br><br>This is documented in ICUActive.[From ICU admission to date of discharge from ICU]