Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
NCT05235334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2023-04-25
Summary
The primary objective of this study is to evaluate the satisfaction of users with the MySOLIUS device by a non-professional in a home use environment. The secondary objective of this study is to demonstrate the safety and effectiveness of the MySOLIUS device in the improvement of mood/quality of life score.
Conditions
- Usability
- Quality of Life
Interventions
- DEVICE
-
MySOLIUS
MySOLIUS is a portable light therapy device that is designed to deliver a small amount of targeted ultraviolet B (UVB) light to trigger the body's natural production of vitamin D.
Sponsors & Collaborators
-
BeneSol, Inc. dba SOLIUS
lead INDUSTRY
Principal Investigators
-
Jashin J Wu, MD · Office of Jashin Wu, M.D.
-
Chih-ho Hong, MD · Dr. Chih-ho Hong Medical Inc.
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-12
- Primary Completion
- 2023-04-12
- Completion
- 2023-04-12
- FDA Device
- Yes
Countries
- United States
- Canada
Study Locations
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