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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056650
Recruitment Status : Terminated (Low enrollment)
First Posted : August 14, 2019
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Bobe, Icahn School of Medicine at Mount Sinai

Brief 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.


Condition or disease Intervention/treatment Phase
Cognitive Performance Drug: L-theanine Dietary Supplement: Caffeine supplement Device: N1 app Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Data Driven Health Decisions in the Wild: A Platform for Actionable N-of-1 Studies
Actual Study Start Date : October 18, 2019
Actual Primary Completion Date : December 22, 2020
Actual Study Completion Date : December 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: Single caffeinated beverage/supplement Dietary Supplement: Caffeine supplement
50-400mg

Device: N1 app
N1 App on mobile device

Active Comparator: Combination caffeine and L-theanine Drug: L-theanine
up to 250 mg

Dietary Supplement: Caffeine supplement
50-400mg

Device: N1 app
N1 App on mobile device




Primary Outcome Measures :
  1. Percent of individuals who reach study completion [ Time Frame: Up to 27 days ]
    Percent of individuals that complete their n-of-1 trial after study initiation


Secondary Outcome Measures :
  1. Percent of completed n-of-1 trials that yield statistically meaningful results. [ Time Frame: Up to 27 days ]
    Percent of individual n-of-1 studies that yield statistically conclusive results, for the comparisons (a) caffeine vs. baseline, (b) L-theanine + caffeine vs. baseline.

  2. Study adherence. [ Time Frame: Up to 27 days ]
    Percent of total actions required for the study (e.g. taking assigned treatments and completing daily cognitive assessment) completed by individual and in aggregate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • US resident
  • 18 years old or over
  • Has an iPhone
  • Regular caffeine drinker

Exclusion Criteria:

  • Pregnant/breastfeeding
  • Any contraindication/health issue in which risk is added by consumption of caffeine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056650


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Jason Bobe Icahn School of Medicine at Mount Sinai
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jason Bobe, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04056650    
Other Study ID Numbers: GCO 18-0756
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Bobe, Icahn School of Medicine at Mount Sinai:
N-of-1
Caffeine
L-theanine
Nootropic
Cognition
Individualized
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents