An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-01-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Allergy and Immunology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No any treatment

Participants randomly assigned to this group will maintain a routine life without any treatments (no use of SAT-008).

Group Type NO_INTERVENTION

No interventions assigned to this group

Use of SAT-008

Participants randomly assigned to this group will be treated by SAT-008 during the study.

Group Type EXPERIMENTAL

SAT-008

Intervention Type DEVICE

SAT-008 is a digital device containing several types of activities related to the immune function of adults.

Interventions

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SAT-008

SAT-008 is a digital device containing several types of activities related to the immune function of adults.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 19 to 50 years
* Received influenza vaccination the previous year
* Scheduled to receive the influenza vaccine
* Voluntarily agrees with a consent form