Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers
Public ClinicalTrials.gov record NCT04056650. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Data Driven Health Decisions in the Wild: A Platform for Actionable N-of-1 Studies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04056650
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
- L-theanine Drug
- Caffeine supplement Dietary Supplement
- N1 app Device
Drug · Dietary Supplement · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 17, 2019
- Primary completion
- Dec 21, 2020
- Completion
- Dec 21, 2020
- Last update posted
- Mar 11, 2021
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04056650, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04056650 live on ClinicalTrials.gov.