A Controlled Study to Investigate the Effect of Multi-wave Light Emitting Diode (LED) Bed on Blood Pressure and Endothelial Function

A Controlled Study to Investigate the Effect of a Multi-wave Light Emitting Diode (LED) Bed on Blood Pressure and Endothelial Function

The objective of this multi-center study is to investigate the effect of a multi-wave LED light bed on blood pressure and endothelial function in pre-hypertensive and mildly hypertensive adults.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Device: LED bed

Detailed Description

Subjects will be instructed to lay in the bed for 20 minutes on their stomach followed by 20 minutes on their back for a total of 40 minutes three times per week for 8 weeks. Subjects will be instructed to begin light treatment on Day 1 after baseline measurements have been collected. Subjects will be required to visit a Wellness Center of Dr. Bryan or Hypertension Institute in Nashville, informed of the study and if agreed will sign the consent form. After consent, subjects will be required to spend about 30 minutes to get baseline measurements. Subjects will then be required to lie in bed for 40 minutes each day three days per week for 8 weeks. Blood pressure and endothelial function tests will be recorded at baseline and after each light treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Rockdale, Texas, United States, 76567
      • Recruiting
      • Nitric Oxide Innovations
      • Contact: Nathan S Bryan, Ph.D.; Phone Number: 512-773-9097; Email: drnathanbryan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female of 18-75 years of age
• If female, subject is not of child bearing potential
• Subjects with seated resting systolic blood pressures between 130-160 mmHg and diastolic between 85-100 mmHg (inclusive) at screening visit
• Subjects with mild to moderate endothelial dysfunction
• Agreement to maintain current level of physical activity and diet throughout the study
• Agrees to comply with study procedures including abstain from coffee at least 14 hours before blood pressure measurement and abstain from physical exercise at least 4 hours before blood pressure measurement
• Has given voluntary, written, and informed consent to participate in the study

Exclusion Criteria:

• Females who are pregnant, breastfeeding, or planning to become pregnant during the course of the study
• Seated office systolic blood pressure outside of the target range (systolic blood pressure <130 mmHg or >160 mmHg) or diastolic blood pressure <85 or >100 mmHg at screening
• The use of natural health products for the treatment of hypertension within 2 weeks of screening
• Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); Valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
• Type I diabetes
• Unstable medical conditions that in the opinion of the Principle Investigator preclude the subject from participating in the study
• Alcohol or drug abuse within the last 6 months
• Participation in a clinical research trial within 30 days prior to randomization
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LightStim LED Bed; Full body LED bed device.	Device: LED bed; Low risk FDA cleared full body LED bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertension	The primary efficacy outcome to be analyzed is the between-group changes from baseline (Day 0) to end of study (Day 60) in daytime mean systolic and diastolic BP and endothelial function, measured using a triplicate readings using AHA guidelines and MaxPulse, respectively.	8 weeks

Collaborators and Investigators

• Sponsor: LED Intellectual Properties, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2018
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Light bed hypertension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No