Clinical trial NCT02785133: Safety and Feasibility of Polychromatic Light Emitting Diode for Peripheral Catheter Illumination During Peripheral Intravenous Delivery of Normal Saline
Official title: A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Fatigue
Lead sponsor: UVLrx Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 3063
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study uses a prospective non-randomized, non-controlled design. Five-hundred (500) subjects having previously received a peripheral intravenous therapy will be enrolled into a single treatment group. The purpose of the study is to evaluate the safety, feasibility, and improved energy levels following treatment with a low-light source integrated into an existing peripheral intravascular catheter. The absence of a control group is based on the following reason:This is a pilot investigation to establish a baseline understanding of the safety, feasibility, and cursory utility of polychromatic light emitting diodes integrated into an existing 20-gauge 1.0 inch intravenous catheter to improve self-reported overall subject energy levels.

Detailed description: This study uses a prospective non-randomized, non-controlled design. Five-hundred (500) subjects having previously received a peripheral intravenous therapy will be enrolled into a single treatment group. The purpose of the study is to evaluate the safety, feasibility, and cursory utility of a low-light source integrated into an existing peripheral intravenous catheter. The absence of a control group is based on the following reason: This is a pilot investigation to establish a baseline understanding of the safety, feasibility, and cursory utility of polychromatic light emitting diodes integrated into an existing 20-gauge 1.0 inch peripheral intravascular catheter to improve self-reported overall subject energy levels based on the change in Epworth Sleepiness scores.

Peripheral intravascular therapy has been used for decades as an effective therapy to maintain proper hydration and electrolyte levels, and has been deemed a non-significant medical procedure. Peripheral intravascular therapy can be infused with various molecular agents such as supplements (Vitamin B12) for the purpose of improving energy levels and overall quality of life. However, the use of normal saline as a standard alone helps improve hydration and cell function. Low-energy light therapy has been established as an alternative treatment for a myriad of medical conditions. Light-based therapy stimulates photoreceptors found within cells and can improve overall cellular bioenergetics. The concurrent administration of low-light therapy and peripheral intravascular normal saline therapy may serve as a viable therapy for the treatment for improvement in subject quality of life and energy levels Accordingly, this study is designed to assess the safety, feasibility, and cursory improvement in self-reported energy levels following intervention of low-light therapy integrated into a standard peripheral intravascular catheter.

Eligibility criteria: Inclusion Criteria:

* Voluntarily signed informed consent form
* Ages 18-70
* Completed urine pregnancy examination with negative result
* Self-reported energy level of \>4 on the Epworth sleepiness test
* No breastfeeding for 3 months prior to enrollment

Exclusion Criteria:

* Active infection along potential intravenous catheter sites
* Pacemaker
* Currently taking prescription blood thinning medications (i.e. Warfarin)
* Suffering from a chronic, progressive blood disorder, such as blood cancer (Thalassemia, Lymphoma, Myeloma, etc.)
* Use of anti-inflammatory medications on a chronic basis (i.e. ibuprofen, aspirin, and steroids)
* Suffering from blood clotting disorders (hypercoagulable condition, thrombocytosis, etc.)
* Clinically significant anxiety and/or depression
* Participated in a clinical study in the last 30 days
* Clinical Cardiac Disease
* Active Infection

Primary outcomes:
measure: The use of polychromatic light therapy delivered through an intravascular catheter for the improvement in self-reported subject energy levels
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: The improvement in subject quality of life using a five (5)-point GRA
timeFrame: 10 weeks
measure: Subject satisfaction based on five (5)-point satisfaction questionnaire
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Lozano Medical Clinic
state: Texas
Study officials:
affiliation: Maloney Insights
name: Ryan J Maloney
role: STUDY_DIRECTOR
References: