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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
| S-Alpha Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No any treatment | No Intervention | Participants randomly assigned to this group will maintain a routine life without any treatments (no use of SAT-008). | |
| Use of SAT-008 | Experimental | Participants randomly assigned to this group will be treated by SAT-008 during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAT-008 | Device | SAT-008 is a digital device containing several types of activities related to the immune function of adults. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 1, Week 5, Week 13 |
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Baseline |
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Week 1 (a week following baseline) |
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Week 5 (five weeks following baseline) |
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Week 13 (thirteen weeks following baseline) |
| Rate of adherence to SAT-008 | To assess a degree to which participants follow SAT-008 | Week 1 (a week following baseline) |
| Rate of adherence to SAT-008 | To assess a degree to which participants follow SAT-008 | Week 5 (five weeks following baseline) |
| Rate of adherence to SAT-008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Seok Chang, MD, PhD | addchang@snu.ac.kr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37179746 | Derived | Choi JP, Ayoub G, Ham J, Huh Y, Choi SE, Hwang YK, Noh JY, Kim SH, Song JY, Kim ES, Chang YS. Exercise With a Novel Digital Device Increased Serum Anti-influenza Antibody Titers After Influenza Vaccination. Immune Netw. 2023 Feb 27;23(2):e18. doi: 10.4110/in.2023.23.e18. eCollection 2023 Apr. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Participants will be randomly assigned to one of two study arms. One group (treatment) will receive an experimental digital device for 13 weeks while the other group (control) will maintain daily activity as usual.
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To assess a degree to which participants follow SAT-008
| Week 13 (thirteen weeks following baseline) |