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Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs

Quality of Life Clinical Trial

Official title:
Light House- Pilot Study Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs

Clinical Trial 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.

Clinical Trial Description

After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be sent a study device to use in their home environment. Prior to beginning treatment with the device, participants will fill out a quality of life questionnaire. Participants will use the device twice per week, once for treatment on the front side and once for treatment on the back side of the body. Participants will use the device twice a week for 16 weeks, for a total of 32 treatments. After the 16 week treatment duration, participants will fill out a final quality of life questionnaire and a device usability questionnaire. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05235334
Study type Interventional
Source BeneSol, Inc. dba SOLIUS
Contact
Status Completed
Phase N/A
Start date October 12, 2021
Completion date April 12, 2023
View Details
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