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? 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.
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 measures the real world effects of improving sleep quality. This unlocks claims that match the benefits your customers want to see.
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.
This objective measure directly quantifies the amount of increased sleep participants are getting as a result of your product's effects.
Sleep latency refers to the ability to fall asleep at night. Establish how much your product helps your consumers actually get to sleep.
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.
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 refers to the ability to wake up feeling refreshed. Our team determines how much your product improves morning wakefulness.
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.
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 Franklin 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.
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."