Sleep DisturbanceNCT07781332
A Trial to Examine the Efficacy of a Supplement Gummy to Improve Sleep Quality and Quantity
A study testing Sleep Gummy Intervention in people with Sleep Disturbance and Poor Sleep Quality, run by DTBE, LLC dba FlavCity at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sleep Disturbance, Poor Sleep Quality, Insomnia (Self-reported, Non-diagnosed)
- What is being tested?
- Sleep Gummy Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Sleep Gummy Intervention
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Gummy InterventionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Gummy Intervention | Experimental | Not described Receives: Dietary Supplement: Sleep Gummy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 1, and Day 7
Change in Quantity of Deep Sleep
Assessed via Fitbit Inspire 3 sleep tracker data
Measured: Baseline, Day 1, and Day 7
Change in Quantity of REM Sleep
Assessed via Fitbit Inspire 3 sleep tracker data
Measured: 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)
Measured: Baseline, Day 1, and Day 7
Change in Frequency of Waking Up in the Night
Assessed via Fitbit Inspire 3 sleep tracker data
Measured: Baseline, Day 1, and Day 7
Change in Heart Rate Variability (HRV)
Assessed via Fitbit Inspire 3 sleep tracker data
Measured: Baseline, Day 1, and Day 7
Secondary outcomes (4)
Perceived Effectiveness of Product at Improving Sleep
Assessed via self-reported product perception questionnaire
Measured: Day 1 and Day 7
Perceived Effectiveness of Product at Improving Energy Levels
Assessed via self-reported product perception questionnaire
Measured: Day 1 and Day 7
Perceived Effects of Product Compared to Previous Sleep Products
Assessed via self-reported product perception questionnaire
Measured: Day 1 and Day 7
Enjoyment of the Product
Assessed via self-reported product perception questionnaire
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2023
- Primary completion10 Sep 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- DTBE, LLC dba FlavCity
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781332
- Sponsor's protocol ID
- 20373
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Examine the Efficacy of a Supplement Gummy to Improve Sleep Quality and Quantity
- ClinicalTrials.gov ID
- NCT07781332
- Acronym / sponsor ID
- 20373
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- DTBE, LLC dba FlavCityIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Gummy Intervention | Experimental | Dietary Supplement: Sleep Gummy Intervention |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Gummy InterventionAll 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. | Dietary supplement | Sleep Gummy Intervention |
Primary outcome
Change in Sleep Quality Score (SQS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 1, and Day 7
Assessed via Fitbit Inspire 3 sleep tracker data
Change in Quantity of REM Sleep
Time frame: Baseline, Day 1, and Day 7
Assessed via Fitbit Inspire 3 sleep tracker data
Change in Sleep Quantity
Time frame: 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
Time frame: Baseline, Day 1, and Day 7
Assessed via Fitbit Inspire 3 sleep tracker data
Change in Heart Rate Variability (HRV)
Time frame: Baseline, Day 1, and Day 7
Assessed via Fitbit Inspire 3 sleep tracker data
4 secondary outcomes
Perceived Effectiveness of Product at Improving Sleep
Time frame: Day 1 and Day 7
Perceived Effectiveness of Product at Improving Energy Levels
Time frame: Day 1 and Day 7
Perceived Effects of Product Compared to Previous Sleep Products
Time frame: Day 1 and Day 7
Enjoyment of the Product
Time frame: Day 1 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Gummy Intervention in people with Sleep Disturbance and Poor Sleep Quality, run by DTBE, LLC dba FlavCity at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality Score (SQS (time frame: Baseline, Day 1, and Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.