NCT05521243 - An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

64

Conditions

Sleep Sleep Disturbance Sleep Hygiene

Interventions

Beam Organics Dream PowderDIETARY_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 StrengthDIETARY_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

PlaceboDIETARY_SUPPLEMENT

The main ingredients in the placebo are: Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor

Eligibility

Sex: ALLMin age: 24 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 weeks

Secondary Outcomes

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.