Sleep Quality

Clinical trials for sleep-enhancing natural products

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 SLEEP BOOSTING STUDIES

"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 focus on identifying sleep disturbances. This helps to identify individuals who may have a disorder such as apnea or insomnia. But these fail to capture improvements to sleep among a general population–the people who purchase your products.

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? Nutraceuticals Research Institute helps you meet this challenge with our proprietary Nutraceuticals Research Institute Sleep Scale (NRI-SS).

The NRI-SS 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.

A natural products sleep trial at Nutraceuticals Research Institute 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 measures the real world effects of improving sleep quality. This unlocks claims that match the benefits your customers want to see.

Sleep Quantity

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

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.

Cognition

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

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.

Emotional Health

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

Sleep Inertia

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

Dim Light Melatonin

If your trial needs lab tests, dim light melatonin onset assesses the circadian rhythm and can provide laboratory evidence of improved sleep cycles.

Flat lay composition with sleep eye mask, dream book and alarm clock on dark blue background. Healthy sleeping concept.

A young woman sleeping with a eye covering mask.

Good night and healthy sleeping concept. Top view sleeping accessories on dark blue background. Flat lay composition with sleep eye mask, pink dream book, alarm clock, confetti. Insomnia treatment.

Sweet dreams. Top view close-up of beautiful young African woman in tank top lying in bed and sleeping

SLEEP ENHANCING CLINICAL TRIALS

Sleep is a normal, natural, yet highly complex physiological process that plays a role in literally every single health related outcome. Improving this process leads to a ripple effect across the entire spectrum of health.

Working with Nutraceuticals Research Institute for a high quality clinical trial with a sleep-related outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:

reduces morning drowsiness
improves sleep quality
supports healthy sleep
alleviates occasional sleepiness
diminishes the effects of poor quality sleep

Sleep may be included in your trial as a primary endpoint for sleep-specific claim substantiation. It is also frequently included as a secondary or exploratory endpoint for products that target outcomes which may influence sleep.

Even if sleep is not the primary focus of your product, including it as a secondary outcome can increase your potential claims. For example, improving stress management is known to boost sleep quality. These secondary outcomes provide additional claim substantiation supporting your target outcome.

Questions about Sleep Quality Trials

Is the NRI Sleep Scale validated?

We love talking about our proprietary suite of psychometric measurement instruments!

These tools were developed to far exceed recommendations in the FDA's guidance on the use of Patient Reported Outcome Measures (PROMs) for the substantiation of labeling claims. The scale contains a combination of subjective and objective data which are aggregated to produce total scores on each of the sleep related subdomains.

Each of our measures are validated and norm-referenced in a population of healthy adult females. Our development priorities include elimination of floor or ceiling effects in this priority population as well as ensuring that each domain has highly precise sensitivity to change.

Our sleep scale was developed and pilot tested with focus groups and qualitative research to ensure face and content validity. It was then tested for psychometric properties using confirmatory factor analysis and item response theory. Internal reliability was determined via Cronbach's alpha.

Our sleep subscales have Cronbach's alpha scores ranging from .82 to .90, which is an ideal range for both exceeding minimum standards for internal reliability while avoiding redundancy and participant burden.

Confirmatory factor analysis confirmed that each subscale measures a single latent factor, with each subscale contributing to the broad latent factor of sleep quality. Factor loadings were all below 0.5, SRMRs were below 0.8, and coefficient of determinations were above 0.8.

In item response theory testing using graded response modeling, each item in the final version of the scale was found to be highly discriminating with IRT discrimination (trait) parameters all above 1.5 and over 50% of item trait parameters above 2.0. Difficulty parameters and test information curves identified that the test is most reliable within +/- 1.5 standard deviations of the mean.

Practically speaking, this means that the test is calibrated to changes to sleep quality among an average American female adult population and is capable of identifying changes that go both above and below the norm. This ensures that our measures capture the totality of your product's effects on each sleep related subdomain.

How long does a sleep trial take?

We create each and every trial around your product's key benefits. Your product will never be forced into some pre-determined timeline. The amount of time required for your product to produce effects is going to be the driving factor in the trial's total duration.

As a general rule, plan on 6-8 weeks from contract execution to the first participant's start date. This time is for protocol development and obtention of ethical authorizations/registrations. This is the most important timeframe of the entire study as it lays the groundwork for a trial that meets our high standards of quality and is capable of staying on the target timeline.

Following the first participant's start date, we typically recommend adding 2 months to the total intervention period for us to hand-select each participant in your study among our nationwide community of participants. This means that a 1-week aromatherapy sleep intervention would require approximately 9 weeks for this phase, whereas a 3-month nutraceutical intervention would require approximately 5 months.

After all data are collected, our team audits each dataset to ensure accuracy. We then clean the data, construct the outcome variables from the data collected, and begin statistical analysis. This phase takes 4-6 weeks on average. More complex studies with multiple outcomes can take several months.

Once outcomes are confirmed, we immediately provide you a quick review of the findings. Our team then spends another 2-4 weeks creating a long-form technical report that goes into precise details of the entire study, a submission-ready scientific manuscript for publication of the findings, and a full color lookbook which contains the technical report contents as well as attention catching graphs and charts. This ensures that everyone on your team, from legal to scientific to marketing, has access to the findings in the form that best meets their needs.

How does the use of a custom protocol affect our budget?

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. 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.

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

Can a sleep outcome be added to another trial?

YOU KNOW YOUR PRODUCT WORKS; WE'LL HELP YOU PROVE IT.

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

Meet with a Scientist