- Clinical trials -

Sleep Quality

Many natural products claim to boost sleep quality; show your customers the power of your product with a clinical trial.

 

clinical trials for improved sleep

Worldwide, consumers spend hundreds of billions on sleep each year. Supplements which can improve sleep quality are poised to capitalize on that lucrative market, but only if they have scientific evidence of their effects. 

Study after study reveals that consumers prefer to use nutraceuticals or supplements to enhance sleep quality, yet figuring out what actually works presents a challenge. A clinical trial demonstrating your product's sleep enhancing abilities makes a powerful statement to your customers about your product. Clinically proven sleep enhancing effects give your brand an edge few can attain.

With a published clinical trial, you can also unlock new claims about your product's actions on the human body, legally and ethically making claims that your product boosts sleep quality and prevents daytime drowsiness. 

Documenting just how much your product protects human health proves consumer confidence in your product's efficacy. It also serves as claim substantiation, which the FDA and FTC require you to have before marketing your product for sleep health. 

Sleep Quality Claim Substantiation

High quality clinical trials, developed to demonstrate your product's unique effects within your target market, are required by regulatory authorities for any marketing claims regarding sleep support. 

With properly designed and implemented clinical trials, you can unlock the ability to legally and ethically make claims such as: 

  • For relief of occasional sleeplessness 

  • Promotes restful sleep  

  • Sleep aid for daytime energy 

  • Supports healthy sleep 

  • Soothing sleep

While it is commonly believed these claims can be made by anyone, so long as they include the FDA disclaimer (i.e. These claims have not been evaluated...), or that claims can be made so long as the product's ingredients are cited in existing clinical studies, such misconceptions can be costly and dangerous to your brand's reputation.  Franklin Health Research can help your sleep enhancing products earn the right to make these claims, confidently assuring your customers of your product's efficacy and your brand's integrity. 

0%

of American adults experience poor or insufficient sleep at least once a month

0

of willing trial participants are in the Franklin Health research database

0%

of nutraceutical clinical trials fail to meet recruitment deadlines

outcome measures for sleep quality

Clinical trials provide many benefits, including documentation of product efficacy. This involves measuring the effect of your product in a treatment group and comparing it to a placebo group using statistical tests which can establish whether or not the difference in sleep quality can be attributed to your product. The key to this process is outcome measurement. 

 If the wrong tool is used to measure sleep quality, your entire trial is at risk of failure.

Accurately measuring sleep quality and being able to document improvements to sleep quality is the foundation of a clinical trial, yet the overwhelming majority of natural products trials on sleep use measures designed to screen for disease states such as insomnia or sleep apnea. These tools are borrowed from pharmaceutical research which is designed to capture levels of sickness, not levels of health. The wrong measurement tool artificiality decreases the size of your product's effects and may even deliver false negatives.  

Tools to measure insomnia or sleep apnea are incapable of accurately capturing the benefits of a product that boosts sleep quality for the average consumer of natural products. This failure to accurately measure your product's effects can destroy your clinical trial. Franklin Health Research solves this common problem through the use of proprietary sleep quality measurement tools developed exclusively for the natural products industry. 

 

waking up rested

 

Franklin Sleep Quality Scale (FSQS)

To address this need, the interdisciplinary Franklin Health Research team created and scientifically validated the first–and only–measurement of sleep quality that quantifies changes in sleep quality among a healthy group of individuals. Not only does this protect your study from false negatives, it is capable of correctly capturing the true size of your product's benefits among those who are most likely to be consuming your product. 

This comprehensive scale captures a wide range of sleep quality symptoms, including objective factors such as duration, sleep latency, and sleep inertia, as well as subjective factors such as satisfaction–delivering the effects your customers care about. 

The sleep quality scale includes ten distinct domains: Sleep Latency, Reliance on Sleep Aids, Sleep Maintenance, Sleep Quantity, Sleep Inertia, Daytime Sleepiness, Cognitive Effects, Temperament, Social Effects, and Productivity. 

This holistic approach enables our researchers to capture not only the true size of your product's effects on sleep quality but also to pinpoint exactly where your product's biggest effects can be found. 

Unlike tools used to measure disease status, the Franklin suite of measurement tools were validated for use in healthy populations which resemble the most common purchasers of natural products and nutraceuticals. This ensures that your study's population matches your consumers–a critical, yet often overlooked, point of compliance for substantiating product claims. 

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pink sleep mask on blue
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THE PROCESS OF STUDYING YOUR Sleep enhancing PRODUCT

Each clinical trial project begins with a 30-60 minute virtual meeting, allowing our team to obtain a comprehensive overview of your product's unique features and your marketing goals for this clinical trial. Does your product help pregnant women reduce sleep disturbances? Or is it targeted towards middle aged professionals suffering from reduced productivity? Perhaps it focuses on elderly adults who struggle to fall–and stay– asleep? Whatever the market, our team can ensure that your trial is customized to meet your specific marketing goals and associated compliance requirements. 

Once we're familiar with your needs, our team of trial experts will design a proposal based on the features of your sleep supporting product. We'll ensure the dosing strategy matches your product's formulation and delivery, that the duration is sufficient to capture measurable change, and that the population is the exact population who will benefit most from using your product. And we'll develop each of these features keeping your budget in mind. 

working with franklin

When choosing a research firm to work with your products, it's important to find the right fit. Most research organizations specialize in pharmaceutical development and conduct natural product studies on the side. The danger to this approach is they typically fail to capture the nuance of natural products and apply inappropriate research methodologies. These clinical trials can quickly become extremely costly, time consuming, and labor-intensive projects, adding bloat to the budget and still failing to meet the unique needs of the natural products industry.

From its inception as an institution of higher education in 2013, Franklin Health Research has always focused exclusively on natural products. Our college programs taught some of the nation's leading herbalists and aromatherapists, and our researcher team is comprised of experts trained in both integrative health and advanced research methods. 

Our expertise also allows us to build your trial from the group up using strategies that protect it from common sources of failure. Many trials suffer from recruitment failure, loss to followup, and woefully inadequate statistical strategies. We've developed unique and innovative approaches to protect your study from these common yet disastrous hurdles. From a comprehensive nationwide database of study participants to an attentive participant support and management team, our role is to anticipate and solve vulnerabilities before they cause problems with your trial. 

 

Clinical Trials for Sleep Enhancement

Ready to get started? Schedule your FREE 30-minute consultation with our research team to discuss your strategies and needs. 

 

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