At Home Setting Clinical Trial
Official title:
A Non Invasive Intervention Study Performed by Subjects Themselves at Home; Evaluation of Study Infrastructure by Measuring the Effect of Caffeine on Attention and Alertness
Subjects will perform experiments in an at home-setting. The effect of caffeine in coffee will be tested in subjects with computer tests on attention and alertness. Comparison of the results with published results from controlled experiments will indicate the effectiveness of home experiments.
There is increasing interest in the general public in measuring health parameters at home,
instead of in a medical setting. Many tests for measuring health parameters are commonly
available in drug stores as well as online. When structured, this trend may also be used for
performing a randomized intervention trial.
The current study is aimed to evaluate the procedure of performing a non invasive
intervention study by subjects themselves performing the tests at home.
The study is designed as a randomized, placebo-controlled, double blind, crossover study.
Subjects have to consume a cup of coffee after an overnight fast. Coffee will be prepared
from instant coffee containing either regular coffee or decaff coffee. Each intervention
will be given twice.
Effects on alertness and attention will be established by three computerized tests provided
by Quantified Mind. The tests will be performed by the subjects at t=0 (baseline, prior to
coffee consumption) and t=1h, one hour after coffee consumption, in one go. Each test will
be performed during 5 minutes. During the training session the participants will be
instructed to get acquainted with the task.
The evaluation of the study concerns the effect of caffeine in the at home setting versus
published results, as well as reproducibility of the results.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment