SleepNCT05657808
Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes
A study testing Rest Study Active Product 1.1 Usage, Rest Study Active Product 1.2 Usage and Rest Study Active 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, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other 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?
- Rest Study Active Product 1.1 Usage, Rest Study Active Product 1.2 Usage and Rest Study Active Product 2.1 Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,152 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 15 Apr 2024
- 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, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
- Resides in the United States
- Endorses better sleep as a primary desire
- Selects sleep, looking to improve their sleep, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
- 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
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address
- The calculated validated health survey (PRO) measurement result is less than mild severity/impairment
- Reports a diagnosis of liver or kidney disease
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
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- Reports current enrollment in a clinical trial
- Lack of reliable daily access to the internet
- Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
- Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or monoamine oxidase inhibitors (MAOIs)
- Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: New York Heart Association (NYHA) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle™ Rest 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Sleep and Other Health Outcomes
A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.
Read the detailed description
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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
- Rest Study Active Product 1.1 Usage, Rest Study Active Product 1.2 Usage, Rest Study Active Product 2.1 Usage, Rest Study Active Product 2.2 Usage, Placebo Control Form 1
- 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.
Rest Study Active Product 1.1 UsageDietary supplement
Participants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks.
Rest Study Active Product 1.2 UsageDietary supplement
Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.
Rest Study Active Product 2.1 UsageDietary supplement
Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks.
Rest Study Active Product 2.2 UsageDietary supplement
Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.
Placebo Control Form 1Dietary supplement
Participants will use Placebo Control Form 1 as directed for a period of 6 weeks.
Placebo Control Form 2Dietary supplement
Participants will use Placebo Control Form 2 as directed for a period of 6 weeks.
Placebo Control Form 3Dietary supplement
Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.
Rest Study Active Product 3.1 UsageDietary supplement
Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks.
Placebo Control Form 4Dietary supplement
Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.
Rest Study Active Product 4.1 UsageDietary supplement
Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.
Rest Study Active Product 4.2 UsageDietary supplement
Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.
Rest Study Active Product 4.3 UsageDietary supplement
Participants will use Radicle Rest Active Product 4.3 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: Placebo Control Form 1 |
| Placebo Control 2 | Placebo comparator | Rest Product Form 2 - control Receives: Dietary Supplement: Placebo Control Form 2 |
| Active Product 1.1 | Experimental | Rest Product Form 1 - active product 1 Receives: Dietary Supplement: Rest Study Active Product 1.1 Usage |
| Active Product 1.2 | Experimental | Rest Product Form 1 - active product 2 Receives: Dietary Supplement: Rest Study Active Product 1.2 Usage |
| Active Product 2.1 | Experimental | Rest Product Form 2 - active product 1 Receives: Dietary Supplement: Rest Study Active Product 2.1 Usage |
| Active Product 2.2 | Experimental | Rest Product Form 2 - active product 2 Receives: Dietary Supplement: Rest Study Active Product 2.2 Usage |
| Placebo Control 3 | Placebo comparator | Rest Product Form 3 - control Receives: Dietary Supplement: Placebo Control Form 3 |
| Active Product 3.1 | Experimental | Rest Product Form 3 - active product 1 Receives: Dietary Supplement: Rest Study Active Product 3.1 Usage |
| Placebo Control 4 | Placebo comparator | Rest Product Form 4 - control Receives: Dietary Supplement: Placebo Control Form 4 |
| Active Product 4.1 | Experimental | Rest Product Form 4 - active product 1 Receives: Dietary Supplement: Rest Study Active Product 4.1 Usage |
| Active Product 4.2 | Experimental | Rest Product Form 4 - active product 2 Receives: Dietary Supplement: Rest Study Active Product 4.2 Usage |
| Active Product 4.3 | Experimental | Rest Product Form 4 - active product 3 Receives: Dietary Supplement: Rest Study Active Product 4.3 Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep disturbance
Mean difference in sleep disturbance 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 (6)
Change in fatigue
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Measured: 6 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where higher scores correspond to greater cognitive function)
Measured: 6 weeks
Change in anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Measured: 6 weeks
Change in mood (emotional distress)
Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression)
Measured: 6 weeks
Change in libido
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest)
Measured: 6 weeks
Minimal clinical importance difference (MCID) in sleep disturbance
Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
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 posted20 Dec 2022
- Study start9 Jan 2023
- Primary completion4 Dec 2023
- Study completion15 Apr 2024
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 sex at birth then randomized to one of the study arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,152 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
- NCT05657808
- Sponsor's protocol ID
- RADX-2301
- Status last verified
- May 2024
- First submitted
- 12 Dec 2022
- Last updated
- 20 May 2024
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle™ Rest 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Sleep and Other Health Outcomes
- ClinicalTrials.gov ID
- NCT05657808
- Acronym / sponsor ID
- RADX-2301
- Conditions
- Sleep, Sleep Disturbance, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,152 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 20 Dec 2022 (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, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.
Detailed description
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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
- 12
- Model description
- Participants will be stratified based on sex at birth then randomized to one of the study arms
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Placebo Control Form 1Rest Product Form 1 - control |
| Placebo Control 2 | Placebo comparator | Dietary Supplement: Placebo Control Form 2Rest Product Form 2 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Rest Study Active Product 1.1 UsageRest Product Form 1 - active product 1 |
| Active Product 1.2 | Experimental | Dietary Supplement: Rest Study Active Product 1.2 UsageRest Product Form 1 - active product 2 |
| Active Product 2.1 | Experimental | Dietary Supplement: Rest Study Active Product 2.1 UsageRest Product Form 2 - active product 1 |
| Active Product 2.2 | Experimental | Dietary Supplement: Rest Study Active Product 2.2 UsageRest Product Form 2 - active product 2 |
| Placebo Control 3 | Placebo comparator | Dietary Supplement: Placebo Control Form 3Rest Product Form 3 - control |
| Active Product 3.1 | Experimental | Dietary Supplement: Rest Study Active Product 3.1 UsageRest Product Form 3 - active product 1 |
| Placebo Control 4 | Placebo comparator | Dietary Supplement: Placebo Control Form 4Rest Product Form 4 - control |
| Active Product 4.1 | Experimental | Dietary Supplement: Rest Study Active Product 4.1 UsageRest Product Form 4 - active product 1 |
| Active Product 4.2 | Experimental | Dietary Supplement: Rest Study Active Product 4.2 UsageRest Product Form 4 - active product 2 |
| Active Product 4.3 | Experimental | Dietary Supplement: Rest Study Active Product 4.3 UsageRest Product Form 4 - active product 3 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
- Resides in the United States
- Endorses better sleep as a primary desire
- Selects sleep, looking to improve their sleep, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
- 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 (11 listed)
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address
- The calculated validated health survey (PRO) measurement result is less than mild severity/impairment
- Reports a diagnosis of liver or kidney disease
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
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 |
|---|---|---|
| Rest Study Active Product 1.1 UsageParticipants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.1 |
| Rest Study Active Product 1.2 UsageParticipants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.2 |
| Rest Study Active Product 2.1 UsageParticipants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 2.1 |
| Rest Study Active Product 2.2 UsageParticipants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks. | Dietary supplement | Active Product 2.2 |
| Placebo Control Form 1Participants will use Placebo Control Form 1 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 1 |
| Placebo Control Form 2Participants will use Placebo Control Form 2 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 2 |
| Placebo Control Form 3Participants will use Placebo Control Form 3 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 3 |
| Rest Study Active Product 3.1 UsageParticipants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 3.1 |
| Placebo Control Form 4Participants will use Placebo Control Form 4 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 4 |
| Rest Study Active Product 4.1 UsageParticipants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 4.1 |
| Rest Study Active Product 4.2 UsageParticipants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks. | Dietary supplement | Active Product 4.2 |
| Rest Study Active Product 4.3 UsageParticipants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks. | Dietary supplement | Active Product 4.3 |
Primary outcome
Change in sleep disturbance
Time frame: 6 weeks
Mean difference in sleep disturbance 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)
6 secondary outcomes
Change in fatigue
Time frame: 6 weeks
Change in cognitive function
Time frame: 6 weeks
Change in anxiety
Time frame: 6 weeks
Change in mood (emotional distress)
Time frame: 6 weeks
Change in libido
Time frame: 6 weeks
Minimal clinical importance difference (MCID) in sleep disturbance
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 20 May 2024.
- 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 Rest Study Active Product 1.1 Usage, Rest Study Active Product 1.2 Usage and Rest Study Active 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 11 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 20 May 2024. 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 disturbance (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 20 May 2024.