Health Products for Sleep Disorders

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

1145 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products, such as anticoagulants, antidepressants, and others listed in the exclusion criteria. If you're on any of these, you may need to stop them to participate.

What data supports the effectiveness of this treatment for sleep disorders?

The study on relaxation and sleep compression for late-life insomnia found that treatments like relaxation and sleep compression improved self-reported sleep, suggesting that similar approaches might help with sleep disorders. Additionally, a pilot study showed that individualized activities increased nocturnal sleep and reduced daytime napping in cognitively impaired elderly adults, indicating potential benefits for sleep improvement. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The safety of sleep-promoting medications varies, with melatonin receptor agonists having the lowest rate of adverse events (unwanted side effects) and non-benzodiazepine benzodiazepine receptor agonists having the highest. Histamine antagonists have the most favorable risk-benefit profile, suggesting they might be a safer first choice for treating insomnia. ^{6 7 8 9 10}

How is Radicle Rest Active Study Product unique for treating sleep disorders?

Radicle Rest Active Study Product 1.1 and 2.1 may be unique because they could involve natural ingredients, which are commonly used for sleep but often lack comprehensive data on their effectiveness and safety. This treatment might offer a novel approach by potentially combining natural components with a structured usage plan, unlike standard pharmaceutical options. ^{11 12 13 14 15}

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

This trial is for individuals experiencing sleep disorders who are interested in testing health and wellness products designed to improve sleep. Specific eligibility details aren't provided, but typically participants must meet certain health conditions.

Inclusion Criteria

Resides in the United States

I am 21 years or older and understand my participation will involve sex-specific aspects.

I could see at least a 20% improvement in my main health issue.

Exclusion Criteria

Lack of reliable daily access to the internet

Reports current enrollment in another clinical trial

I've had a major illness or surgery in the last 3 months that could be risky for my health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the study product or placebo for 6 weeks to assess impact on sleep and related health outcomes

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Radicle Rest Active Study Product 1.1 Usage
• Radicle Rest Active Study Product 2.1 Usage

Trial Overview The study tests two different Radicle Rest active products against two placebo controls to see if they help with sleep issues. It's a randomized trial, meaning participants are assigned to one of the four groups by chance and neither they nor the researchers know which group they're in (double-blind).

Participant Groups

Group I: Placebo Control 4.1.0 Experimental Treatment 1 Intervention

Rest Product 4 - control

Group II: Active Product 4.1.1 Experimental Treatment 1 Intervention

Rest Product 4 - active product 1

Group III: Active Product 2.1 Experimental Treatment 1 Intervention

Rest Product Form 2 - active product 1

Group IV: Active Product 1.1 Experimental Treatment 1 Intervention

Rest Product Form 1 - active product 1

Group V: Placebo Control 2 Placebo Group 1 Intervention

Rest Product Form 2 - control

Group VI: Placebo Control 1 Placebo Group 1 Intervention

Rest Product Form 1 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Findings from Research

Patients who received education on using sleep-enhancing tools (like eye masks and white noise machines) experienced a significant reduction in fatigue compared to those who only received general sleep information, indicating that targeted education can improve patient outcomes.

While the education intervention showed benefits in fatigue, it did not significantly affect other sleep-related issues or the length of hospital stay, suggesting that while helpful, the approach may need to be part of a broader strategy for improving overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. Farrehi, PM., Clore, KR., Scott, JR., et al.[2019]

In a 6-month open-label extension study involving 360 adults with primary insomnia, eszopiclone significantly improved sleep quality, reduced sleep latency, and enhanced daytime functioning without evidence of tolerance.

Patients who switched from placebo to eszopiclone maintained and even further improved their sleep and daytime function over the 6-month period, with the treatment being well tolerated, aside from a mild side effect of unpleasant taste.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Roth, T., Walsh, JK., Krystal, A., et al.[2022]

The use of herbal preparations for sleep issues among adults in the U.S. has significantly increased from 2.5% to 12.4% over the past decade, highlighting a growing interest in alternative remedies.

Health care professionals need to be informed about the pharmacological properties of commonly used herbal sleep aids and wake-promoting products to better educate their patients on safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. Merritt, SL., Gyllenhaal, C., Peterson, SD., et al.[2015]

Melatonin receptor agonists have the lowest rate of adverse events (43.1 per 1000), while non-benzodiazepine benzodiazepine receptor agonists have the highest (255.0 per 1000), indicating a significant difference in safety profiles among insomnia medications.

Benzodiazepines showed the highest efficacy in improving sleep outcomes with an effect size of 1.94, while melatonin receptor agonists had the lowest efficacy (0.109), suggesting that histamine antagonists may offer the best risk-benefit ratio for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. Cheung, JMY., Scott, H., Muench, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Examining the feasibility of implementing specific nursing interventions to promote sleep in hospitalized elderly patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Relaxation and sleep compression for late-life insomnia: a placebo-controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of individualized activities on the sleep of nursing home residents who are cognitively impaired: a pilot study. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Perceived insufficient rest or sleep--four states, 2006. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Sleep movements and poor sleep in patients with non-specific somatic complaints--II. Affective disorders and sleep quality. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Rehabilitation is compromised by arousal and sleep disorders: results of a survey of rehabilitation centres. [2016]

12. France pubmed.ncbi.nlm.nih.gov

[Objective improvement of sleep disorders in the elderly by a health education program]. [2016]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The use of natural products for sleep: A common practice? [2018]

14. Denmark pubmed.ncbi.nlm.nih.gov

Sleep habits and sleep complaints in Austria: current self-reported data on sleep behaviour, sleep disturbances and their treatment. [2015]

15. United States pubmed.ncbi.nlm.nih.gov

Screening for idiopathic REM sleep behavior disorder: usefulness of actigraphy. [2021]