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The primary objective is to explore the relationship between experimental condition (placebo or PowerOff) and sleep quality between pre-study and post-study. In addition, volunteers will wear actigraphy watches that collect objective measures of sleep, such as total sleep time, and these data points will be compared pre- and post-study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PowerOff | Experimental | PowerOff is a nutraceutical and a blend of nine ingredients for sleep, including: melatonin; California Poppy; L-Cystine; Glycine; and Magnolia Officinalis |
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| Placebo | Placebo Comparator | The placebo pill will be manufactured at the same facility and appear identical in all aspects. However, the control agent will feature non-active ingredients with regards to sleep.Capsules will be instructed to commence on day 7 of the study after baseline appointment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Capsule | Dietary Supplement | Composition of the placebo is 100% organic rice flour, manufactured at a facility New York State licensed to produce pharmaceuticals. Capsules will be instructed to commence on day 7 of the study after baseline appointment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on Pittsburgh Sleep Quality Index (PSQI) | measures quality and pattern of sleep in adults. It differentiates "poor" from "good" sleep quality | 12 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Duration | collected objectively via the sleep monitoring actigraphy wristwatch | 12 Days |
| Sleep Duration | collected subjectively using self-reported questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girardin Jean-Louis, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| POWEROFF Capsule | Dietary Supplement | blend of California Poppy Aerial Part Extract, L-Cystine, L-Theanine,GABA (proprietary Phosphatidylcholine-Palmitic Acid-Oleic Acid Complex), 5-HTP, Magnolia Officinalis Bark Extract, Glycine, Melatonin with 0.5mg of Vitamin B6 (as pyridoxal-5-phosphate). |
|
| 12 Days |