Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers

Study Summary

The growing consumer-grade molecular and digital wellness market is generating unprecedented volumes of information to support decision-making around individual health. Current trends suggest the demand for personalized health information, tools, and services will continue to rise in the next decade. What is missing is a reliable, individualized way to turn this data into action. Dialogue around consumer health often ignores the disconnect between measurements and goals. For example, monitoring one's weight is not the same as losing weight, and counting steps is not the same as lowering blood pressure. If individuals are to benefit from data, they must be able to relate changes in their personal data to targeted changes in actions and outcomes. There is a great need and opportunity to adapt the tools and capabilities of modern computer science, statistics, and clinical trial design to the needs of individual patients and consumers. The team at the Institute for Next Generation Healthcare (INGH) has created a smartphone-based app ("N1 app") and study platform that together allow individuals to design, implement, and analyze methodologically sound, statistically robust studies of their personal health data. The focus of the platform will be the creation of single-participant randomized crossover studies, known as n-of-1 trials. The platform employs informatics-based intelligence that automates study design and analysis while simultaneously maintaining high standards of statistical rigor and reproducibility. These novel methods and tools are designed to empower individuals to make rational, data-driven choices about their own health, maximizing the benefit all will receive from new and existing sources of personal health data.

Primary Outcome

Percent of individuals that complete their n-of-1 trial after study initiation

Interventions

• DRUG L-theanine
• DIETARY_SUPPLEMENT Caffeine supplement
• DEVICE N1 app