Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 6:50 AM
Study NCT ID:
NCT05235334
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2022-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
Sponsor:
BeneSol, Inc. dba SOLIUS
Organization:
Study Overview
Official Title:
Light House- Pilot Study Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: