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| Name | Class |
|---|---|
| Scripps Clinic | OTHER |
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Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Group | Experimental | Patients in this group will receive melatonin 3mg orally at 9pm. |
|
| Placebo Group | Placebo Comparator | Patient in this group will receive a matching placebo pill orally at 9pm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | Melatonin is the dietary supplement we are using in delirium prevention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delirium as measured by CAM Assessment | Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission. | Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Sleep Quality, measured by nocturnal sleep duration | Nocturnal sleep duration will be measured by wireless actigraphy. | nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first. |
| Objective sleep quality, measured by number of nighttime wakenings |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 6 month | |
| Disposition following hospitalization | We want to determine if the patient is discharged to home, to a post-acute care facility, or to a new type of living facility that was different from their prior living situation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas McCarthy, MD | Scripps Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33051948 | Derived | Jaiswal SJ, Kang DY, Wineinger NE, Owens RL. Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. J Sleep Res. 2021 Jun;30(3):e13205. doi: 10.1111/jsr.13205. Epub 2020 Oct 13. | |
| 29729237 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2024 | |
| Reset | Oct 3, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2024 | Oct 3, 2024 |
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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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| Placebo | Other | Patients in this group will receive a matching placebo pill. |
|
We will measure the number of nighttime wakenings using wireless actigraphy. |
| nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first. |
| Objective sleep quality, measured by sleep latency | We will measure sleep latency (time to fall asleep) using wireless actigraphy. | nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first. |
| Subjective sleep quality, measured by Richards-Campbell sleep questionnaire | Patients will be asked to fill out the Richards-Campbell sleep question, which uses a visual analog scale for 5 questions that are designed to assess a patient's perceived sleep quality. | once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first. |
| 1 day following hospital discharge or at the 2 week time end point of the study. |
| Subjective sleep quality following hospital discharge. | Patients will be given an insomnia questionnaire over the phone at 6 months. | 6 months following hospital discharge |
| Jaiswal SJ, McCarthy TJ, Wineinger NE, Kang DY, Song J, Garcia S, van Niekerk CJ, Lu CY, Loeks M, Owens RL. Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial. Am J Med. 2018 Sep;131(9):1110-1117.e4. doi: 10.1016/j.amjmed.2018.04.009. Epub 2018 May 3. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |