SLEEP QUALITY

Clinical trials for sleep-enhancing natural products

healthy sleep

Over 70% of Americans experience poor sleep at least once a month. For 70 million Americans, these sleep issues are chronic. Poor quality sleep has a far-reaching impact on human health, ranging from increased risk of diseases such as hypertension and diabetes to practical outcomes such as decreased productivity, daytime sleepiness that results in car accidents or on-the-job mistakes, and cognitive fatigue. Worldwide, consumers spend billions on sleep products each year in an effort to improve sleep. 

You've got a product that can help consumers solve this problem. But today's consumers want more than brand assurance; they want evidence. A clinical trial provides the evidence your brand needs to build consumer trust and help the world sleep better. 

ENDPOINTS FOR SUCCESS

"Good sleep" is hard to define. It's even harder to measure. That's why most tools available for sleep-focused clinical trials focus on diseases such as insomnia or sleep apnea instead of sleep quality. But your solution is a natural product, not a pharmaceutical. Your product improves health rather than treats disease. Your trial endpoints need to match your product's effects, and most importantly, these endpoints shouldn't result in FDA warning letters.  

So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical boosts sleep among people who have poor sleep but are not diseased? Franklin Health Research helps you meet this challenge with our proprietary Franklin Health Sleep Scale (FHSS). 

The FHSS is the first tool of its kind developed exclusively for the natural products industry to measure improvements to sleep. This comprehensive measurement focuses on a holistic approach and includes multiple definitions of "improved sleep." Unlike existing insomnia-focused scales, this tool concentrates on the wide range of areas in which sleep can be improved and focuses on real world outcomes that matter to your consumers. 

Measurement can make or break your sleep study

Why do you need the FHSS? The endpoint you choose and the tools in which you measure these endpoints are the the most fundamental and critical elements of your sleep study's design. This measurement is the tool that will be used to capture and document any and all improvements to sleep that your product delivers. 

There are three factors to consider with a measurement tool: validity (it measures what it is intended to measure), reliability (it does so consistently–time after time), and sensitivity (it is sensitive enough to capture even small changes in the specific effect). Collectively, these three elements determine the quality of a measurement tool, which plays a role in establishing whether or not it is fit for purpose.

When a clinical trial for sleep supplements rely on insomnia screening tools (such as the Pittsburgh Sleep Quality Index) or expensive sleep labs, they place the entire study at risk by using measures that are not fit for purpose. These tools might be valid and reliable, but they are not sensitive to changes among healthy people. They have a primary goal of diagnosing disease. They are good tools for drug trials, but poor tools for natural product studies. 

A successful natural product sleep trial requires tools that were developed specifically for use in the natural products industry and are capable of documenting a holistic range of improvements in sleep quality among people who are already considered to be healthy.

Using the wrong tool to measure sleep quality puts your entire study at risk of a false negative. 

Not only does having the right endpoint measure boost your trial's chances of success, it ensures that your trial meets the FDA and FTC's requirements for claim substantiation. These regulatory agencies identify appropriate and clearly measured endpoints as essential for successful claim substantiation. Outcome measures are also one of the primary criteria the FDA uses when evaluating the quality of a substantiation trial. 

When a research firm uses insomnia tools or sleep labs as an endpoint for a sleep enhancing claim, it can place your entire brand at risk. Not only does it dramatically weaken the quality of your trial, it may even result in an inability to substantiate your claim. In extreme cases, it can even cause the FDA to reclassify your sleep promoting natural supplement or aromatherapy blend as an unauthorized pharmaceutical, opening the door to millions in compliance-related costs.  

How we design your sleep trial

Franklin reduces this vulnerability by exclusively relying on our proprietary suite of fit for purpose endpoint measures which our team developed specifically to meet these FDA and FTC guidelines. 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. 

These outcomes are measured through real-world effects, ensuring that your study findings not only keep regulatory agencies happy, but that they meet the desires of your customers. Your customers want to know if your product helps reduce daytime sleepiness or if it can help them with cognitive drowsiness. We help you achieve that. 

A natural products sleep trial at Franklin Health will typically focus on 7 - 8 primary endpoints, though your trial's endpoints will be hand-selected by our research team to match your sleep product's greatest effects. Our most commonly used endpoints include: 

daytime sleepiness

Daytime Sleepiness

Daytime sleepiness measures the real world effects of improving sleep quality. This unlocks claims that match the benefits your customers want to see. 

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Cognition

Mental fatigue is one of the most dangerous effects of poor sleep quality. This allows our team to directly quantify how your product improves lives. 

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Quantity of Sleep

This objective measure directly quantifies the amount of increased sleep participants are getting as a result of your product's effects. 

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Sleep Latency

Sleep latency refers to the ability to fall asleep at night. Establish how much your product helps your consumers actually get to sleep. 

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Productivity

Productivity often suffers as a result of poor sleep. This endpoint allows us to calculate just how much your product helps consumers at work or home. 

emotions

Emotional Effects

Tired people are grumpy people; our team uses this endpoint to ascertain how much emotional wellbeing improves as a result of better sleep. 

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Sleep Inertia

Sleep inertia refers to the ability to wake up feeling refreshed. Our team determines how much your product improves morning wakefulness. 

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Dim Light Melatonin Onset

If your trial needs lab tests, this marker assesses the circadian rhythm and can provide laboratory evidence of improved sleep cycles. 

ENROLLING YOUR TARGET MARKET

To meet regulatory requirements, your trial needs to establish that it improves sleep, not that it cures disease. Your task is to document improvements to health in people who are technically already healthy. But let's be honest, your customers may be technically healthy, but they are not sleeping well. If they were, they wouldn't be searching for your help! 

That's why identifying the right people to enroll in your trial is critical. Our multidisciplinary team includes public health professionals–experts who can pinpoint exactly who is at the greatest risk of poor sleep quality. By targeting disease-free people who have poor quality sleep, we're able to capture the individuals who are most likely to buy your products and who are most likely to benefit from your products. This boosts your trial's chances of success while also meeting the FDA and FTC requirements.

Claim substantiation also requires that the people in your study's trials match the people who consume your products. Different people respond differently to natural products, so it's critical that the people in your trials are similar to the people who will actually use your essential oils, herbal products, or nutraceuticals. If your average customer is pregnant women, your trial needs to be conducted on a group of pregnant women. If you market to college students, your study should include them. 

Enrollment, Protocol Compliance, and Drop-outs 

Identifying the right group of people to participate is one thing; getting them into the study and keeping them in a study is a whole different ballgame. Across the industry, over 80% of clinical trials are unable to meet enrollment goals; this inadequacy is a leading cause of study failure. Some firms address this challenge by lowering their standards–enrolling anyone and everyone they can find into a trial. This approach looks great at first, but the resulting poor compliance and large drop-out rates destroy the quality of a study. This introduces a form of bias to your dataset, dramatically reducing the quality of the trial and therefore, the potential for your trial to substantiate a claim. 

Keeping people who enrolled into a study involved in the study and using the product correctly is critical for your trial's success. You already know that people need to actually use your product to experience its benefits. If the people in your study are only sporadically taking it or sloppily using it, the resulting data will be unable to validate your product's effects. Similarly, large dropout rates will also reduce the quality of your study while increasing the risks of a false negative. 

The MY Franklin Health Community

Franklin takes a different approach to enrollment and retention. Rather than simply accepting noncompliance and dropouts as inevitable, we've invested in the cultivation of a large community of willing and eager volunteers who want to join your trial. The community we've built is also demographically consistent with the populations most likely to purchase natural sleep aids. 

By focusing on the participant experience, we're able to find the right enrollees for your study and keep them engaged throughout your trial. The end result for you? Recruitment costs that are a fraction of industry norms. Not only that, we average a 99% retention rate in our trials with near perfect protocol compliance. 

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WE ARE NATURAL HEALTH PEOPLE TOO 

One of the biggest challenges to natural product research is finding someone who understands both the natural health field and clinical research. Most research firms are pharmaceutical firms first, with nutrition or supplement research as a side gig. These firms simply take the same assembly line approach and cram your unique sleep enhancing product into a preexisting strategy. But your highly complex natural product isn't a drug. Your endpoint isn't a disease. Cramming it into these study designs falls short when it comes to capturing what makes your oil blend or natural product actually work. The end result is usually an outrageously expensive trial that suffers from poor quality design and ultimately ends in failure. 

As a natural health research firm, we take a different approach. Each and every researcher on our team is also a trained natural health professional. Our team includes aromatherapists, herbalists, health coaches, dietitians, and a range of other specializations that cross the holistic health spectrum. We know the interactions between substances such as botanicals, nutraceuticals, or essential oils, and sleep onset, maintenance, and quality. This allows us to understand your product in ways no other firm can. We know your product doesn't rely on pharmaceutical-like mechanisms of action or protocols, and we won't treat it that way.

If your sleep supporting product is an aromatherapy blend, our expert aromatherapists will work with you to ensure that every element of your study maximizes the unique chemistry your oil blend has to offer. If your product is a supplement, you'll enjoy researchers who are nutrition experts and herbalists. You'll never have to explain the phytochemistry or holistic approaches your product uses to achieve its goals. We know how to maximize your product's effects, boosting not only your chances of success but the level of success your trial achieves.  

As experienced natural health professionals, our team is also familiar with the ways in which natural sleep products are inadvertently misused. We know how to ensure that your aromatherapy blend is dosed sufficiently and applied consistently from day to day. Our culinary experts know how to keep participants consuming your supplement even if they don't like the flavor or texture. These factors are often overlooked by conventional firms but have the potential to make or break your trial. 

WE BOOST YOUR CHANCES OF SUCCESS

Not only will you enjoy the expertise of holistic health experts, your trial will be managed by highly trained clinical researchers. Our research firm is led by a Harvard-trained researcher and each of our team members have graduate training in health research fields. This ensures that your trial meets the highest scientific and methodological standards. 

This expert approach to trial design reduces your chances of a false negative. Far too many natural product trials fail not because the product doesn't work, but because the trial was poorly designed. These problems can involve a study being underpowered, poor choice in endpoint measures, inability to develop an effective intervention protocol, participant dropouts, or sloppy data analysis. 

At Franklin Health, we use our extensive expertise to make you look good. We create sleep enhancing trials based on your product's strongest effects. We ensure that the endpoints for your trial are hand-selected to match the effects your product actually delivers. 

Far too many natural product trials fail not because the product doesn't work, but because the trial was poorly designed.

Our power analysis standard cuts your chances of false negatives in half. In an effort to cut costs, many firms conduct studies that are developed to accept a 20% chance of producing a false negative. Roughly 1 in 5 trials are at risk of falling short of statistical significance simply because they are the wrong size.  We cut that risk in half, designing high powered studies that are more likely to succeed. 

Many others fail due to poor intervention strategies. Doses that are too low, schedules that are too complex for participants to follow, inconvenient preparations, or even improper application approaches can all lead to false negatives. When this happens, the problem isn't that your product doesn't improve sleep, the problem is that most researchers don't know how to help study participants use your product correctly. Our health experts create user-friendly intervention strategies which address all of the complex factors that contribute to study success. 

We also develop comprehensive statistical analysis plans that eliminate the noise from your data, isolating your product's true effects. With simplistic measures, many research firms are incapable of data analysis that sufficiently captures the effects your product can deliver. Our natural product expertise allows our statisticians to identify and neutralize factors which can minimize the effects, producing trial results that accurately display the true size of your product's sleep-enhancing effects. 

A clinical trial helps you gain:

Specificity

Now you can quantify your product's effects. i.e. It improves sleep by XX%! 

Target Marketing

Identify who benefits the most from your product so you can customize marketing campaigns.

Substantiation

Gain credible, high quality substantiation for your proprietary products. 

Protection

Clinical trials protect you from legal challenges, but only if they are high quality. 

Press

Scientific publications or presentations deliver the right kind of media attention.

Expert Allies

Clinical trials help you market to key community leaders including MDs and RNs.  

Free CONSULTATION

Meet with a Researcher

No high pressured sales events; meet directly with a scientist who can help you explore how Franklin can help you promote your sleep products with clinical evidence. 

Meet with a Scientist

YOUr budget

One of the biggest myths in natural product research is that clinical trials cost millions. That may be true for a novel biotech company with products that have dangerous side effects and high-stakes outcomes such as cancer or heart disease. These costs are directly associated with safeguarding the experimental use of untested medications on people who are very sick. 

Pharmaceutical research firms have created procedures and systems which revolve around high risk drugs among high risk populations. Those pricey systems protect patients in these invasive clinical trials, but are wholly inept when it comes to the needs of natural sleep support trials. 

Natural products such as essential oils, nutrition supplements, or herbal creams are self-prescribed at the health food store, not physician-prescribed through a highly regulated pharmacy. Natural products have hundreds if not thousands of years of safe use in human health, unlike novel isolated chemical extracts which lack human history. Natural products boost the structure and function of human health rather than treat diseases. Your sleep enhancing product isn't an experimental pharmaceutical and your trial shouldn't be designed like one either.  

Instead of forcing your sleep enhancing product into an extraneous research model, we design custom trial strategies around your needs. Our expert approach to clinical trial design focuses on the quality of your trial and FDA/FTC natural product-specific guidelines such as those for dietary supplements or cosmetics. We prioritize ethics compliance, data protection, and quality control over wasteful and irrelevant systems borrowed from other industries. Through this approach, we're able to reduce inefficiencies in the research process and eliminate needless overhead costs that are not relevant to the standards for health-enhancing products. We also use cutting-edge designs such as decentralized trials and non-invasive measures. Most importantly, not only does this approach substantially reduce the cost of a clinical trial for your sleep aid, it also improves the quality of the trial. It's a win-win. 

Actual Clinical Trial Costs

So what does this actually look like for your trial? At Franklin, we prioritize transparent pricing. Each and every trial is a bespoke design based on your sleep product's unique needs, with your budget and goals in mind. With our extensive expertise in natural products and clinical research, we're often able to come up with creative solutions to work with any trial budget.

The typical randomized, double-blinded placebo-controlled clinical trial for a sleep promotion supplement varies based on a number of factors. On the lower end, a trial may run anywhere from $45,000-$75,000 for a week-long aromatherapy based sleep study with 60 people. On the upper end, a 3-4 month intervention with larger groups and more complex analyses can run into the mid-$200,000 range. Our scientists will work with you to develop a sleep enhancing trial that captures the real world effects of your product while staying within the confines of your budget. 

Getting started is easy

One

Schedule a FREE, no obligation meeting with a Franklin Health scientist. 

Two

Tell us more about your product and your marketing goals. 

Three

Review our proposals, discuss any changes, and we'll take it from there! 

LEGAL WILL LOVE YOU 

One of the most important reasons to conduct a clinical trial is to boost protection from legal challenges. If you want to say your product improves sleep, the FDA and FTC require you to bring the evidence. Not just any evidence; they require high quality evidence that meets key criteria. 

The FDA identifies these criteria as: study population, study design and conduct, data collection and statistical analysis, and outcome measures. You may have a "successful" trial but if it doesn't meet these quality-based criteria, it doesn't substantiate a claim.

Unfortunately, poor quality trials are common in the natural products industry. Many large firms aren't equipped to manage the unique elements of natural products or to prioritize health-enhancing outcome measures and FDA guidelines. Others may use dubious techniques such as "p-hacking" or conduct multiple analyses without controlling for multiplicity. These may give the appearance of success, but ultimately fail to meet industry standards.  

Here's the catch. Regulatory agencies can easily catch these common mistakes. Quick and cheap trial results that use shoddy statistical approaches don't fool expert statisticians. Neither does a long and overpriced trial conducted by drug researchers who know nothing about natural products. And when these trials are evaluated for quality, your company will be the one that pays the price. 

We take our commitment to the integrity of your trial seriously. The overwhelming majority of our studies are published in peer reviewed literature and/or presented at academic or scientific conferences. This not only provides valuable free press for your sleep enhancing product, it also provides additional evidence that your trial is high quality and capable of substantiating your claims. 

Not only do we keep quality at the forefront of what we do, each of our trials are backed by our Five-Point Promise, which details our commitment to ensuring trial outcomes that work, sample populations that matter, natural health expert researchers, high quality research methods, and direct access to researchers–not high pressure sales people or account managers. By focusing on quality over quantity, we're able to deliver high quality clinical trials faster and more affordably than any other firm in the natural products industry. 

LET'S TALK

You know your product improves sleep; we'll help you prove it. 

Schedule a free, no-obligation meeting with a scientist today to learn more about how Franklin can help your product become "clinically proven." 

 

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