SLEEP QUALITY

Questions About Sleep-Improving Trials

• Is your 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 improving 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 your approach of custom protocol creation affect the 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-related outcome be added to another trial?

  Absolutely! Many, if not most, natural products have some type of effect on sleep quality in consumers. Given the substantial ripple effect of sleep on every system in the body, including sleep as a secondary or even exploratory outcome in a trial is an easy–and affordable–way to unlock additional claims.