Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older, admitted to the ICU
Expected length of stay of at least 48 hours
Not mechanically ventilated
Able to take oral medications.
Disqualifiers
Mechanically ventilated
Currently using melatonin prior to ICU admission,
Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.
Pregnant or lactating individuals
Trial design
Design model
Single group
Treatments tested in this trial
Melatonin
Drugpatients in this arm will recieve melatonin
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Melatonin armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Efficiency as measured by total sleep time over time in bed
These measures are obtained from the sleep profiler. Higher sleep efficiency is better.
Time frame
From enrollment to the end of 48 hours of the last subject's participation in the study2
, Total sleep time in hours and minutes
These measures are obtained from the sleep profiler.
Time frame
From enrollment to the end of 48 hours of the last subject's participation in the study3
, Delta to Theta ratio
These measures are obtained from the sleep profiler Higher delta to Theta ratio is better
Time frame
From enrollment to the end of 48 hours of the last subject's participation in the study4
, Arousal Index
These measures are obtained from the sleep profiler. Lower arousal index is better
Time frame
From enrollment to the end of 48 hours of the last subject's participation in the studyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: