An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity

Study Overview
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Brief Summary
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This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period.

Official Title
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An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity

Conditions
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Sleep, Sleep Disturbance, Sleep Hygiene

Intervention / Treatment
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* Dietary Supplement: Beam Organics Dream Powder
* Dietary Supplement: Beam Organics Dream Powder Extra Strength
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported issues with sleep Must be in good overall health with no unstable medical conditions Must own a wearable sleep tracker (i.e., Apple Watch, FitBit, Whoop, etc.) Must be willing to discontinue any supplements meant to assist with sleep. Exclusion Criteria: Females who are pregnant or breastfeeding Diagnosis of insomnia or sleep apnea Taking a prescription medication that affects sleep Anyone with a pre-existing condition that would prevent them from adhering to the protocol Anyone with a known history of past severe allergic reactions

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo + Dream Powder<br>Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks. | Dietary Supplement: Beam Organics Dream Powder<br>* The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern<br>Dietary Supplement: Placebo<br>* The main ingredients in the placebo are: Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor<br>|
| Experimental: Placebo + Dream Powder Extra Strength<br>Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks. | Dietary Supplement: Beam Organics Dream Powder Extra Strength<br>* The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern<br>Dietary Supplement: Placebo<br>* The main ingredients in the placebo are: Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Changes in Sleep Quality as reported by questionnaires | Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week. | 6 Weeks | 
| Perceived Changes in Sleep Quantity as reported by questionnaires | Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week. | 6 weeks | 
| Perceived Changes in Sleep Habits as reported by Questionnaires | Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week. | 6 weeks | 
| Participant Perceptions of Sleep | Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine changes in device measured sleep across the six week trial. | Sleep will be measured with fitness trackers to provide an objective outcome measure of sleep across the six week trial. Both sleep time and sleep quality will be examined. Participants will report their sleep data from the previous week at Baseline, Week 2, Week 4, and Week 6. | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Sleep Disturbance, Sleep Quality, Sleep Quantity