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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin arm | Experimental | 3mg Melatonin will be administered orally to all subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | patients in this arm will recieve melatonin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency as measured by total sleep time over time in bed | These measures are obtained from the sleep profiler | From enrollment to the end of 48 hours of the last subject's participation in the study |
| , Total sleep time in hours and minutes | These measures are obtained from the sleep profiler | From enrollment to the end of 48 hours of the last subject's participation in the study |
| , Delta to Theta ratio | These measures are obtained from the sleep profiler These measures are obtained from the sleep profiler | From enrollment to the end of 48 hours of the last subject's participation in the study |
| , Arousal Index | These measures are obtained from the sleep profiler | From enrollment to the end of 48 hours of the last subject's participation in the study |
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Inclusion Criteria:
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. Hemodynamically stable as determined by the treating ICU physician Able to provide informed consent or have consent provided by a legally authorized representative.
Exclusion Criteria:
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 Those individuals with a comfort measures-only status
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jag Sunderram, MD | Contact | 732-235-7038 | sunderja@rwjms.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jag Sunderram | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |