Insomnia (Self-reported, Non-diagnosed), Poor Sleep Quality, Sleep Disturbance
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSleep Gummy Intervention
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.
Sponsors
DTBE, LLC dba FlavCity
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * 20-50 years old * Self-reported issues with sleep * Willing to discontinue any over-the-counter medications, prescription medications, and herbal supplements used to assist with sleep * Willing to maintain their standard sleep pattern and activity level for the duration of the study * Be generally healthy and not living with any uncontrolled chronic disease
Exclusion criteria
* Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea * Vegan participants (as this product contains beeswax which is not suitable for participants on a vegan diet) * Women who are pregnant, breastfeeding, or trying to conceive (TTC) * 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 * Has undergone in the last three weeks, is currently undergoing, or planning to undergo any significant medical procedures in the next three weeks * A history of severe allergic reactions including but not limited to any of the product's ingredients * Anyone who is a heavy drinker (a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week) * Individuals taking prescription or over-the-counter medication that affects sleep * Use of any herbal remedies which can affect sleep * Has a job that disrupts nighttime sleep (e.g., third shift or night shift work) * Anyone who is using illicit drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality Score (SQS | Baseline, Day 1, and Day 7 | Change from baseline in sleep quality score as assessed using the validated Sleep Quality Scale (SQS) self-reported questionnaire. |
| Change in Fitbit Sleep Score | Baseline, Day 1, and Day 7 | Change from baseline in sleep score measured using the Fitbit Inspire 3 sleep tracker. |
| Change in Sleep Onset Latency | Baseline, Day 1, and Day 7 | Change from baseline in sleep onset latency, measured using the Fitbit Inspire 3 sleep tracker and reported in minutes. |
| Change in Quantity of Deep Sleep | Baseline, Day 1, and Day 7 | Assessed via Fitbit Inspire 3 sleep tracker data |
| Change in Quantity of REM Sleep | Baseline, Day 1, and Day 7 | Assessed via Fitbit Inspire 3 sleep tracker data |
| Change in Sleep Quantity | Baseline, Day 1, and Day 7 | Assessed via Fitbit Inspire 3 sleep tracker data and self-reported questionnaire using the Sleep Quality Scale (SQS) |
| Change in Frequency of Waking Up in the Night | Baseline, Day 1, and Day 7 | Assessed via Fitbit Inspire 3 sleep tracker data |
| Change in Heart Rate Variability (HRV) | Baseline, Day 1, and Day 7 | Assessed via Fitbit Inspire 3 sleep tracker data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Effectiveness of Product at Improving Sleep | Day 1 and Day 7 | Assessed via self-reported product perception questionnaire |
| Perceived Effectiveness of Product at Improving Energy Levels | Day 1 and Day 7 | Assessed via self-reported product perception questionnaire |
| Perceived Effects of Product Compared to Previous Sleep Products | Day 1 and Day 7 | Assessed via self-reported product perception questionnaire |
| Enjoyment of the Product | Day 1 and Day 7 | Assessed via self-reported product perception questionnaire |
Countries
United States
Outcome results
None listed