A Trial to Examine the Efficacy of a Supplement Gummy to Improve Sleep Quality and Quantity
NCT07781332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-24
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.
Conditions
- Sleep Disturbance
- Poor Sleep Quality
- Insomnia (Self-reported, Non-diagnosed)
Interventions
- DIETARY_SUPPLEMENT
-
Sleep 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 & Collaborators
-
Citruslabs
collaborator INDUSTRY -
DTBE, LLC dba FlavCity
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2023-09-10
- Completion
- 2023-09-10
Countries
- United States
Study Locations
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