This single-group trial evaluates the efficacy of FlavCity's Sleep Gummy supplement on sleep health in adults aged 20-50 who self-report issues with sleep. Forty participants will take one sleep gummy nightly (30 minutes before bed) for 7 days while wearing a Fitbit Inspire 3 sleep tracker to monitor objective sleep metrics. Participants will complete study-specific questionnaires and report sleep tracker data at Baseline, Day 1 (the day after first use), and Day 7. The study is conducted entirely virtually. Primary outcomes focus on sleep quality and quantity (including time to fall asleep, deep sleep, REM sleep, and grogginess upon waking), assessed via the validated Sleep Quality Scale (SQS) and sleep tracking biomarkers. Secondary outcomes assess participant perceptions of the product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
All enrolled participants receive FlavCity Sleep Gummy, one gummy taken orally 30 minutes before bedtime (at least one hour after the evening meal) daily for 7 consecutive days.
Citruslabs
Las Vegas, Nevada, United States
Change in Sleep Quality Score (SQS
Change from baseline in sleep quality score as assessed using the validated Sleep Quality Scale (SQS) self-reported questionnaire.
Time frame: Baseline, Day 1, and Day 7
Change in Fitbit Sleep Score
Change from baseline in sleep score measured using the Fitbit Inspire 3 sleep tracker.
Time frame: Baseline, Day 1, and Day 7
Change in Sleep Onset Latency
Change from baseline in sleep onset latency, measured using the Fitbit Inspire 3 sleep tracker and reported in minutes.
Time frame: Baseline, Day 1, and Day 7
Change in Quantity of Deep Sleep
Assessed via Fitbit Inspire 3 sleep tracker data
Time frame: Baseline, Day 1, and Day 7
Change in Quantity of REM Sleep
Assessed via Fitbit Inspire 3 sleep tracker data
Time frame: Baseline, Day 1, and Day 7
Change in Sleep Quantity
Assessed via Fitbit Inspire 3 sleep tracker data and self-reported questionnaire using the Sleep Quality Scale (SQS)
Time frame: Baseline, Day 1, and Day 7
Change in Frequency of Waking Up in the Night
Assessed via Fitbit Inspire 3 sleep tracker data
Time frame: Baseline, Day 1, and Day 7
Change in Heart Rate Variability (HRV)
Assessed via Fitbit Inspire 3 sleep tracker data
Time frame: Baseline, Day 1, and Day 7
Perceived Effectiveness of Product at Improving Sleep
Assessed via self-reported product perception questionnaire
Time frame: Day 1 and Day 7
Perceived Effectiveness of Product at Improving Energy Levels
Assessed via self-reported product perception questionnaire
Time frame: Day 1 and Day 7
Perceived Effects of Product Compared to Previous Sleep Products
Assessed via self-reported product perception questionnaire
Time frame: Day 1 and Day 7
Enjoyment of the Product
Assessed via self-reported product perception questionnaire
Time frame: Day 1 and Day 7
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