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Completed

NCT Number: NCT05521243

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

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.

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Key information

Conditions

Sleep Behavior Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Disturbance Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

24 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beam Organics Dream Powder

Dietary Supplement

The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern

Beam Organics Dream Powder Extra Strength

Dietary Supplement

The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern

Placebo

Dietary Supplement

The main ingredients in the placebo are:

Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor

Primary outcomes

  1. Perceived Changes in Sleep Quality as reported by questionnaires

    Time frame: 6 Weeks

    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.

  2. Perceived Changes in Sleep Quantity as reported by questionnaires

    Time frame: 6 weeks

    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.

  3. Perceived Changes in Sleep Habits as reported by Questionnaires

    Time frame: 6 weeks

    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.

  4. Participant Perceptions of Sleep

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Examine changes in device measured sleep across the six week trial.

    Time frame: 6 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Beam

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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