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NCT04056650 · ClinicalTrials.gov registry record · Phase 4
Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
NCT04056650 is a Phase 4 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 57 participants.
The verdict
NCT04056650, a Phase 4 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
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.
Interventions
- DRUG L-theanine
- DIETARY_SUPPLEMENT Caffeine supplement
- DEVICE N1 app
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2020-12-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04056650
The ClinicalTrials.gov registry entry for NCT04056650 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which L-theanine is the first listed.
NCT04056650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04056650 about?
NCT04056650 is a clinical study titled "Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers". 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 the current status of trial NCT04056650?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2019-10-18. Estimated completion is 2020-12-22.
What interventions are being tested in trial NCT04056650?
The interventions under investigation include: L-theanine (DRUG), Caffeine supplement (DIETARY_SUPPLEMENT), N1 app (DEVICE).
Who is sponsoring clinical trial NCT04056650?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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