Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05657808
Other study ID # RADX-2301
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date April 15, 2024

Study information

Verified date May 2024
Source Radicle Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4152
Est. completion date April 15, 2024
Est. primary completion date December 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 105 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Intervention

Dietary Supplement:
Rest Study Active Product 1.1 Usage
Participants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks.
Rest Study Active Product 1.2 Usage
Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.
Rest Study Active Product 2.1 Usage
Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks.
Rest Study Active Product 2.2 Usage
Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.
Placebo Control Form 1
Participants will use Placebo Control Form 1 as directed for a period of 6 weeks.
Placebo Control Form 2
Participants will use Placebo Control Form 2 as directed for a period of 6 weeks.
Placebo Control Form 3
Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.
Rest Study Active Product 3.1 Usage
Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks.
Placebo Control Form 4
Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.
Rest Study Active Product 4.1 Usage
Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.
Rest Study Active Product 4.2 Usage
Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.
Rest Study Active Product 4.3 Usage
Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks.

Locations

Country Name City State
United States Radicle Science, Inc Del Mar California

Sponsors (1)

Lead Sponsor Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 6 weeks
Secondary 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) 6 weeks
Secondary 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) 6 weeks
Secondary 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) 6 weeks
Secondary 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) 6 weeks
Secondary 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) 6 weeks
Secondary 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) 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4

External Links