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Sleep DisturbanceNCT07744997

Radicle RestTM VGI: A Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes

A study testing Active Rest Product 1 in people with Sleep Disturbance, run by Radicle Science at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Radicle RestTM VGI: A randomized, double-blind, placebo- controlled study assessing the impact of health and wellness products on sleep and related health outcomes. Read more about this study

Who is it for?
Ages 21 to 105 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Disturbance
What is being tested?
Active Rest Product 1
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
1 siteUnited States
Study dates
11 Aug 2026to 6 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 21 to 105 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

3.1 Inclusion

Participants must meet all the following criteria:

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
  • Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
  • Resides in the United States
  • Has the opportunity for at least 30% improvement in their primary health outcome
  • Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

3.2 Exclusion

Individuals who report any of the following during screening may be excluded from participation:

  • Report being pregnant, trying to become pregnant, or breastfeeding
  • Unable to provide a valid US shipping address and mobile phone number
  • Reports current enrollment in another clinical trial
  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
  • Unable to read and understand English at a 7th grade level
  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
  • NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
  • Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
  • Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
  • Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
  • Lack of reliable daily access to the internet

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Radicle Science Inc.

    Del Mar, California, 92014-2605

Other trials in United States

About this study

Official title: Radicle RestTM VGI: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes

Radicle RestTM VGI: A randomized, double-blind, placebo- controlled study assessing the impact of health and wellness products on sleep and related health outcomes.

Read the detailed description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Being tested
Placebo Rest Control, Active Rest Product 1
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo Rest ControlDietary supplement

    Participants will use their Placebo Rest Control as directed for a period of 6 weeks

  • Active Rest Product 1Dietary supplement

    Participants will use their Active Rest Product 1 as directed for a period of 6 weeks

Study groups in NCT07744997
Study groupRoleWhat they receive
Active Rest Product 1ExperimentalActive Rest Product 1
Receives: Dietary Supplement: Active Rest Product 1
Placebo Rest ControlPlacebo comparatorPlacebo Rest Control
Receives: Dietary Supplement: Placebo Rest Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sleep

    Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

    Measured: 7 weeks

Secondary outcomes (3)

  1. Change in sleep-related impairment

    Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)

    Measured: 7 weeks

  2. Change in mood (emotional distress-depression)

    Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)

    Measured: 7 weeks

  3. Change in fatigue

    Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

    Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start11 Aug 2026
  3. Primary completion6 Aug 2027 (estimated)
  4. Study completion6 Aug 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants must complete all enrollment procedures before stratification and randomization. During enrollment, participants will be stratified by sex assigned at birth, age, and health outcome score, with health outcome scores categorized according to the applicable PROMIS® published scoring guidelines. Participants will then be sequentially randomized to a study group using all stratification factors collectively to ensure balanced allocation across study product groups. Stratification factors include sex assigned at birth (Female, Non-Female), age (21-44, 45-64, 65+ years), and four health outcome score categories, resulting in 24 unique stratification cells (2 × 3 × 4 = 24). Following randomization, participants will receive their assigned study product and an insert containing instructions for product use and study procedures.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07744997
Sponsor's protocol ID
RADX_P_2601_VGI
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Questions about this trial

What is this clinical trial studying?

A study testing Active Rest Product 1 in people with Sleep Disturbance, run by Radicle Science 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?

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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07744997.

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 2 Sep 2026.

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