A close-up of a pile of fresh, ripe cherries, mostly red with a few dark purple ones, some with stems attached.

CASE STUDY

Traditional Herbal Medicines Validated in the Real World:
Open Label Pilot of Herbal Sleep Aid for Sleep Disruption

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) Evaluate product efficacy, drive product development, support claims, and patent application.

Participants

43 participants, 75% female, with moderate to severe symptoms of sleep disruption (as measured by the validated ISI).

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.

Duration

5 week study.

Analytical Methods

2-Tailed t-tests and Mann-Kendall trend over time.

Validation

IRB approved. Study In Review.

Key Results

20%

Increase in Subjective Sleep Quality.

40%

Boosted Daytime Alertness.

15%

Reduction in Feelings of Anxiety.

89%

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

Study Details

Sleep mask with closed eyes design, various crystals, a pink alarm clock, a teddy bear, and a dropper bottle on a beige background.

Introduction

Modern life involves chronic sleep loss, leading to numerous physical and mental health challenges. Clinical insomnia may impact one fifth to one third of the population. As of 2013, average sleep duration was 6.8 hours per night and only 34% of Americans reported sleeping 8 hours or more per night. Finally, chronic prescription sleep aid use 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 and tolerability.

Montmorency tart cherry (prunus cerasus) 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 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 subjective sleep and anxiety in adults with sleep disruption.

A timeline diagram illustrating a study period with screening at the start and end, including key dates such as Day -7 for enrollment, Day 1, Day 8, Day 15, Day 22, Day 28, and Day 29 for study conclusion. The timeline also shows periods labeled as baseline period, product use period, no product use, and different study phases.

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.

A fresh cherry with water droplets on it, sitting on a white surface with a neutral background.

Data Collection

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

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.

Four box plots showing the effects of sleep aid on sleep quality, alertness, insomnia severity, and anxiety symptoms. Each plot compares data with and without a sleep aid, highlighting significant differences.

Vertical timeline with numbered steps, starting at 01 at the top and progressing downwards. The current step is 04.

Vertical timeline with a burgundy circle labeled '03' at the top, connected by a thin vertical line to the bottom.

A vertical numbered timeline with a maroon circle labeled '02' at the top and a thin vertical line extending downward.

A simple vertical timeline with a dark green line, a red circle labeled '01', and a dark red background for the circle.

Study Outcome

Clinical Validation: The study found that the combination of Montmorency tart cherry and Venetron® is a promising sleep aid, warranting further investigation in larger, placebo-controlled 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 Symptoms of 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. The study is presently In Review.

A background of ripe red and dark purple cherries with white text overlay that says 'SIP 2 Sleep' and a clock-like design around the text.

“Our study supported our patent application, has helped us gain attention as a clinically-effective & clinically-studied sleep aid. We’re able to explicitly state that our product reduces symptoms of sleep disruption and anxiousness 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

Website homepage for Sip2Sleep showing a father and child at sunset, with the text promoting improvements in falling asleep and total sleep time for clinical trial participants.

Benefits to Sip2Sleep

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.
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.

Hand holding a small brown bottle labeled 'SIP2 Sleep' with a dropper cap next to a sleep mask and a potted fern on a speckled white surface.

Benefits to
Trial Participants

All participants could view their own results after the study. Putting participant experience at the center of our studies increases participant satisfaction, compliance, and adds to our community of motivated repeat-participants.
Real-time feedback on individual progress, boosting engagement and data-literacy.
89% of participants said they would participate in another People Science study, and recommend People Science studies to friends and family.