The purpose of this exploratory study is to evaluate the efficacy, safety, and feasibility of a novel digital device called SAT-008 in healthy adults.
This clinical study was designed as a single institution, open, controlled, and investigator-led clinical trial to evaluate the efficacy, safety, and feasibility of a novel digital device called SAT-008 in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
42
SAT-008 is a digital device containing several types of activities related to the immune function of adults.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Changes in functions of immunocytes
To measure changes in functions of natural killer cells, T cells, and B cells at 1, 5, and 13 weeks compared to baseline.
Time frame: Baseline, Week 1, Week 5, Week 13
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Time frame: Baseline
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Time frame: Week 1 (a week following baseline)
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Time frame: Week 5 (five weeks following baseline)
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Time frame: Week 13 (thirteen weeks following baseline)
Rate of adherence to SAT-008
To assess a degree to which participants follow SAT-008
Time frame: Week 1 (a week following baseline)
Rate of adherence to SAT-008
To assess a degree to which participants follow SAT-008
Time frame: Week 5 (five weeks following baseline)
Rate of adherence to SAT-008
To assess a degree to which participants follow SAT-008
Time frame: Week 13 (thirteen weeks following baseline)
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