A Crossover Trial to Examine the Efficacy of a Powder to Improve Sleep Quality and Performance
- Conditions
- SleepSleep Disorder
- Registration Number
- NCT07183735
- Lead Sponsor
- Beam
- Brief Summary
This is a randomized, placebo-controlled crossover study to assess the efficacy of BEAM's Dream Powder in improving sleep health among 40 adults. Participants will use a placebo for 2 weeks, followed by the test product for 4 weeks, with sleep data collected via questionnaires and a Fitbit sleep tracker.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Male or female
- 18+ years old
- Self-reported issues with sleeping, falling asleep, or staying asleep.
- Willing to discontinue any supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the study duration.
- Willing to avoid introducing any other supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of this trial.
- Willing to maintain their standard sleep pattern and activity level for the duration of the study.
- Be generally healthy and not live with any uncontrolled chronic disease.
- Diagnosed with any chronic sleep condition, including but not limited to insomnia, narcolepsy, or sleep apnea.
- Women who are pregnant, breastfeeding, or trying to conceive.
- Anyone unwilling or unable to follow the study protocol.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Is currently undergoing, or planning to undergo, any significant medical procedures during the study period.
- Has undergone any surgeries or invasive treatments in the last six months.
- A history of severe allergic reactions, including but not limited to any of the product's ingredients.
- Anyone with a nut allergy.
- Heavy drinkers. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.
- Anyone who uses illicit drugs.
- Use any prescription medication, over-the-counter, or herbal remedies that can affect sleep.
- Have a job that involves working the third or night shifts.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in sleep quality as measured by the Sleep Quality Scale (SQS) Baseline, Week 2, Week 4, Week 6 Sleep quality will be assessed using the self-reported Sleep Quality Scale (SQS), a validated questionnaire evaluating subjective sleep quality.
Change in sleep quantity and architecture as measured by sleep tracker Baseline, Week 2, Week 4, Week 6 Objective sleep metrics (e.g., time to fall asleep, deep sleep, REM sleep, sleep transitions, sleep duration, and frequency of waking) will be collected using a sleep tracking device.
- Secondary Outcome Measures
Name Time Method Change in perceived restfulness as measured by self-reported questionnaire Baseline, Week 2, Week 4, Week 6 Participants will report perceived restfulness levels to assess subjective recovery and rest post-intervention.
Change in overall energy levels as measured by self-reported questionnaire Baseline, Week 2, Week 4, Week 6 Participants will rate their energy levels using a structured questionnaire.
Change in emotional well-being as measured by self-reported questionnaire Baseline, Week 2, Week 4, Week 6 Emotional well-being will be assessed using a validated self-report measure.
Change in cognitive function as measured by self-reported questionnaire Baseline, Week 2, Week 4, Week 6 Cognitive function will be assessed through a participant questionnaire evaluating attention, memory, and mental clarity.
Change in dietary behavior (e.g., hunger levels) as measured by self-reported questionnaire Baseline, Week 2, Week 4, Week 6 Participants will report perceived hunger levels and related dietary behavior using a structured questionnaire.
Trial Locations
- Locations (1)
Citruslabs
🇺🇸Las Vegas, Nevada, United States
Citruslabs🇺🇸Las Vegas, Nevada, United States