SleepNCT06347744
Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes
A study testing Radicle Rest Active Study Product 1.1 Usage and Radicle Rest Active Study Product 2.1 Usage in people with Sleep and Sleep Disturbance, run by Radicle Science at 1 site in United States.
Trial summary
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, Sleep Disturbance, Sleep Disorder
- What is being tested?
- Radicle Rest Active Study Product 1.1 Usage and Radicle Rest Active Study Product 2.1 Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,646 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 16 Jun 2025
- 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 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 surveys (male vs female) employed, when needed
- Resides in the United States
- Endorses better sleep as a primary desire
- Has the opportunity for at least 20% 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
Who cannot join
- 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
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
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- 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 (New York Heart Association) Class Ill 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, antihypertensive, 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, MAOls (monoamine oxidase inhibitors), 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
- Lack of reliable daily access to the internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle Rest™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes
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) endorse a desire for better sleep, (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. 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 baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Conditions
- Sleep, Sleep Disturbance, Sleep Disorder
- Being tested
- Radicle Rest Placebo Control Form 1, Radicle Rest Active Study Product 1.1 Usage, Radicle Rest Placebo Control Form 2, Radicle Rest Active Study Product 2.1 Usage, Radicle Rest Placebo Control 4.1.0
- Medical subject headings
- Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radicle Rest Placebo Control Form 1Dietary supplement
Participants will use their Radicle Rest Placebo Control Form 1 as directed for a period of 6 weeks.
Radicle Rest Active Study Product 1.1 UsageDietary supplement
Participants will use their Radicle Rest Active Study Product 1.1 as directed for a period of 6 weeks.
Radicle Rest Placebo Control Form 2Dietary supplement
Participants will use their Radicle Rest Placebo Control Form 2 as directed for a period of 6 weeks.
Radicle Rest Active Study Product 2.1 UsageDietary supplement
Participants will use their Radicle Rest Active Study Product 2.1 as directed for a period of 6 weeks.
Radicle Rest Placebo Control 4.1.0Dietary supplement
Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks.
Radicle Rest Active Study Product 4.1.1 UsageDietary supplement
Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Rest Product Form 1 - control Receives: Dietary Supplement: Radicle Rest Placebo Control Form 1 |
| Active Product 1.1 | Experimental | Rest Product Form 1 - active product 1 Receives: Dietary Supplement: Radicle Rest Active Study Product 1.1 Usage |
| Placebo Control 2 | Placebo comparator | Rest Product Form 2 - control Receives: Dietary Supplement: Radicle Rest Placebo Control Form 2 |
| Active Product 2.1 | Experimental | Rest Product Form 2 - active product 1 Receives: Dietary Supplement: Radicle Rest Active Study Product 2.1 Usage |
| Placebo Control 4.1.0 | Experimental | Rest Product 4 - control Receives: Dietary Supplement: Radicle Rest Placebo Control 4.1.0 |
| Active Product 4.1.1 | Experimental | Rest Product 4 - active product 1 Receives: Dietary Supplement: Radicle Rest Active Study Product 4.1.1 Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep
Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
Measured: 6 weeks
Secondary outcomes (7)
Change in feelings of anxiety
Mean difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Measured: 6 weeks
Change in fatigue
Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Measured: 6 weeks
Change in mood (emotional distress-depression)
Mean difference in emotional distress score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Measured: 6 weeks
Minimal clinically important difference (MCID) in sleep
Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
Measured: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Measured: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Measured: 6 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start17 Jun 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily K. Pauli, PharmD, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347744
- Sponsor's protocol ID
- RADX-P-2401
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2024
- Last updated
- 6 Oct 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Rest™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT06347744
- Acronym / sponsor ID
- RADX-P-2401
- Conditions
- Sleep, Sleep Disturbance, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,646 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 4 Apr 2024 (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.
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes.
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) endorse a desire for better sleep, (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. 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 baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms.
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Radicle Rest Placebo Control Form 1Rest Product Form 1 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Radicle Rest Active Study Product 1.1 UsageRest Product Form 1 - active product 1 |
| Placebo Control 2 | Placebo comparator | Dietary Supplement: Radicle Rest Placebo Control Form 2Rest Product Form 2 - control |
| Active Product 2.1 | Experimental | Dietary Supplement: Radicle Rest Active Study Product 2.1 UsageRest Product Form 2 - active product 1 |
| Placebo Control 4.1.0 | Experimental | Dietary Supplement: Radicle Rest Placebo Control 4.1.0Rest Product 4 - control |
| Active Product 4.1.1 | Experimental | Dietary Supplement: Radicle Rest Active Study Product 4.1.1 UsageRest Product 4 - active product 1 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 surveys (male vs female) employed, when needed
- Resides in the United States
- Endorses better sleep as a primary desire
- Has the opportunity for at least 20% 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Radicle Rest Placebo Control Form 1Participants will use their Radicle Rest Placebo Control Form 1 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 1 |
| Radicle Rest Active Study Product 1.1 UsageParticipants will use their Radicle Rest Active Study Product 1.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.1 |
| Radicle Rest Placebo Control Form 2Participants will use their Radicle Rest Placebo Control Form 2 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 2 |
| Radicle Rest Active Study Product 2.1 UsageParticipants will use their Radicle Rest Active Study Product 2.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 2.1 |
| Radicle Rest Placebo Control 4.1.0Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 4.1.0 |
| Radicle Rest Active Study Product 4.1.1 UsageParticipants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 4.1.1 |
Primary outcome
Change in sleep
Time frame: 6 weeks
Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
7 secondary outcomes
Change in feelings of anxiety
Time frame: 6 weeks
Change in fatigue
Time frame: 6 weeks
Change in mood (emotional distress-depression)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in sleep
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Time frame: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Time frame: 6 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Time frame: 6 weeks
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 6 Oct 2025.
- Radicle Science, IncLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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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.
Emily K. Pauli, PharmD principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radicle Rest Active Study Product 1.1 Usage and Radicle Rest Active Study Product 2.1 Usage in people with Sleep and 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?
The sponsor lists 5 inclusion and 10 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 6 Oct 2025. 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?
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 (time frame: 6 weeks). 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 6 Oct 2025.