CASE STUDY

Chloe Clinical Case Study:
Open Label Pilot of Herbal Sleep Aid for Insomnia

Study Overview

A look at the study facts, key findings, and real-world implications.

Study Snapshot

Primary focus

Design and execute a full-service, wearable-empowered clinical study of sleep aid Sip2Sleep®, containing Montmorency tart cherry (prunus cerasus) extract and Venetron® (apocynum venetum), to evaluate product efficacy, drive product development, support claims and patent application.

Participants

43 participants, 75% female, with an Insomnia score averaging 19.5

Study Type

Open label pilot, decentralized trial approved by the Advarra Institutional Review Board (IRB)

Study Structure

Participants consumed the supplement nightly for (A) one-week-on, (B) one-week-off in an ABAB design, logging outcomes in the Chloe app and wearing the Fitbit Charge 6.

Duration

5 week study

Data Collection & Analytical Methods

Fitbit and questionnaires. 2-tailed t-tests and Mann-Kendall trend analysis.

Validation

IRB approved. Study under review at Nature Scientific Reports.

Key Results

20%

Improved Sleep Quality

40%

Boosted Daytime Alertness

15%

Reduced Anxiety

Fitbit

Study measures combined validated questionnaires, subjective daily measures, and wearable sleep monitoring using the Fitbit Charge 6.

89%

of participants said they would participate in another People Science study.

Study Details

Introduction

Modern life involves chronic sleep loss, leading to numerous physical and mental health challenges. Clinical insomnia may impact 1/5 to ⅓ of the population. As of 2013, average sleep duration dropped to 6.8 hours per night and only 34% of Americans reported sleeping 8 hours or more per night. Finally, chronic prescription sleep aid use (e.g., Ambien, Gabapentin) is now suspected to contribute to cognitive impairment and dementia. These concerning effects highlight the importance for broader study and discussion of sleep aids with a long history of use, mild potency, and potentially better safety/tolerability.

Montmorency tart cherry is the subject of increasing scientific interest due to its ability to reduce inflammation and oxidative stress, improve recovery from exercise and boost sleep quality. Anti-inflammatory and sleep promoting properties are attributed in part to anthocyanins, which may minimize tryptophan degradation while increasing bioavailability for serotonin synthesis. Additionally, sleep-promoting effects arise from large naturally occurring levels of melatonin. Apocynum venetum or Venetron is believed to increase functional activity of the major inhibitory neurotransmitter, GABA, exerting a mild sedating effect. However, both compounds require wider validation in clinical trials and, until now, had not been studied together. This study investigated whether such a product, called Sip2Sleep®, would improve sleep and anxiety in adults with symptoms of insomnia.

Data Collection

People Science designed a 5-week, open label ABAB decentralized clinical trial in adults with symptoms of moderate to severe insomnia. The study measures combined validated questionnaires, subjective daily measures for assessing within-individual change over time, and wearable sleep monitoring using the Fitbit Charge 6.

The Chloe platform was instrumental in the Sip2Sleep® trial, providing an end-to-end solution for decentralized data collection and seamless participant engagement. All assessments and surveys were administered in the Chloe app, significantly reducing logistical complexity for both the trial sponsor and participants.

Study Design & Execution

To execute a rapid Open Label pilot, People Science utilized its proprietary Consumer Health Learning & Organizing Ecosystem (Chloe). Chloe combines a mobile app with a health research platform designed for companies that prioritize scientific rigor, enabling rapid and cost-effective validation of product claims.

Decentralized Clinical Trials (DCTs) evaluate the impact of novel interventions without the need for in-person doctor’s visits. By combining a mobile app for communication, consent, data entry and visualization, a software backend for clinical operations and a team to manage shipments - all the work of participating in a clinical trial can be done from home. This strategy is speeding every stage of scientific advancement, from cost reduction to study design, recruitment, data collection, monitoring, and data visualization.

Study Outcome

The collaboration yielded statistically significant, publishable results:

Clinical Validation: The study found that the combination of Montmorency tart cherry and Venetron® in this commercially available tincture is a promising sleep aid, warranting further investigation in larger trials.

Improved Sleep Quality: Evening consumption of Sip2Sleep® resulted in consistent improvement in subjective sleep quality and a decrease in insomnia severity.

Boosted Daytime Alertness: Daytime alertness trended upward across the study period, suggesting that these herbs may exert impacts on sleep on days subsequent to when they are taken, and that benefits may increase with longer use.

Reduced Anxiety: Evening consumption of Sip2Sleep® resulted in consistent reduction in anxiety.

These results are consistent with prior studies of individual interventions with either prunus cerasus or apocynum venetum.

“Our study supported our patent application, has helped us gain attention as a clinically-effective & scientifically-proven sleep aid. We’re able to explicitly state that our product reduces insomnia and anxiety symptoms and improves morning alertness. We’ve also been able to add a Science section to our site that shows our results in diverse participants.”

Ruchir Patel, MD
CEO & Founder, Sip2Sleep®, Director of Insomnia and Sleep Institute of Arizona

Benefits to Sip2Sleep

Benefits to
Trial Participants

All participants could view their own results after the study. Putting participant experience at the center of our studies means high participant satisfaction, high compliance, and a growing pool of community participants
Real-time feedback on individual progress, capturing more of participants’ interest.
89% of participants said they would participate in another People Science study, and recommend People Science studies to friends and family.

The trial provided claims for Sip2Sleep® to use in advertising, web materials and in a patent application. Data and preprint are available online for full transparency.
These results position Sip2Sleep® as a credible, natural alternative to traditional sleep aids, enhancing brand reputation in a competitive market. The study’s strong compliance and transparent data, including wearable sleep tracking, bolster consumer trust. With these findings, the product stands out as a scientifically backed solution in the growing sleep aid market, with potential for further expansion through additional research and clinical trials.
This is the first study, to our knowledge, to assess the synergistic effects of Montmorency Cherry and Venetron® on sleep. The study is presently under review at Nature Scientific Reports
Enabled seamless remote participation, reducing logistical barriers and costs associated with in-person visits.
Provided instant insights into participant data, allowing timely adjustments to maximize study effectiveness.
Structured prompts and reminders helped maintain high data quality and participant adherence throughout the trial.