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

NCT05521243 | Completed

• 1 other identifier: 20241
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Sleep Disturbance; Sleep Hygiene

Keywords

Sleep; Sleep Disturbance; Sleep Quality; Sleep Quantity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  6 Weeks

Study Arms (2)

Placebo + Dream Powder

EXPERIMENTAL

Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks.

Dietary Supplement: Beam Organics Dream Powder; Dietary Supplement: Placebo

Placebo + Dream Powder Extra Strength

EXPERIMENTAL

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; Dietary Supplement: Placebo

Interventions

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

Placebo + Dream Powder

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 + Dream Powder Extra Strength

Placebo DIETARY_SUPPLEMENT

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

Placebo + Dream Powder; Placebo + Dream Powder Extra Strength

Eligibility Criteria

• Age: 24 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beam: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Hygiene; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Christopher Hill, PhD

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: May 9, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

US (1)