Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia

Launched by LAKSHMI NUTRACEUTICALS LLC · Mar 5, 2024

Keywords

ClinConnect Summary

The rationale for this study is to determine the effect of a consumer-grade, unique formula called Sip2Sleep®, which is a combination of Montmorency tart cherry extract and Venetron®, a patented, purified, powdered extract derived from the Rafuma leaf, Apocynum venetum, on sleep disturbance in adults. Because this product is currently available in the OTC market across the United States, a consumer-driven, decentralized observational clinical research study is well-suited for examining the effect of this formulation on sleep.

Sleep disturbance is highly prevalent and impacted by many inter...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years old
• • Has self-reported sleep disturbance
• • Insomnia Severity Index (ISI) score of \> 15 at screening
• • Interested in understanding more about the quality of their sleep and chose to use the Sip2Sleep product for sleep
• • Willingness to do a minimum of 1 week wash out of current OTC or other products for sleep (e.g. melatonin, anticholinergics)
• • Willingness to do a minimum of 1 week wash out of any cannabis products
• • Able to receive shipment of the product at an address within the United States If taking prescription hypnotics (e.g. zolpidem, zaleplon, benzodiazepines) or other class of medication for sleep, must be on a stable dose for at least 4 weeks.
• • Able to read and understand English
• • Able to use a personal smartphone
• • Has and is able to use a personal health tracking wearable device (e.g., Apple Watch, Fitbit Smartwatch, Oura Ring, etc.)
• • Able to understand and provide informed consent
• • Able to complete study assessments over 5 weeks
• Exclusion Criteria:
• • Research participants who have no computer, smartphone, and internet access and/or do not use a computer or smartphone
• * The following concomitant therapies are excluded:
• • Participants taking daily prescription medication for sleep (for example, prescription hypnotics like zolpidem, zaleplon, benzodiazepines) not on a stable dose for at least 4 weeks
• • Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
• • Participants receiving any investigational therapies or treatments
• * Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:
• • Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
• • Confirmed diagnosis of Sleep Apnea that is untreated or not well controlled
• • Current or prior psychotic disorder
• • Current or prior Substance Abuse Disorder
• • Current or prior cardiac dysrhythmias (for example, atrial fibrillation, supraventricular tachycardia)
• • Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
• • Allergies or adverse reactions (for example, anxiety) to Montmorency tart cherry extract and/or Venetron®

Trial Officials