NCT05235334

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: BeneSol, Inc. dba SOLIUS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Usability
• Quality of Life

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-12
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2022-02-11
• Last updated: 2023-04-25

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study