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

NCT04006158 | Unknown FDA Device

• 1 other identifier: Light bed hypertension
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LightStim LED Bed

EXPERIMENTAL

Full body LED bed device.

Device: LED bed

Interventions

LED bed DEVICE

Low risk FDA cleared full body LED bed

LightStim LED Bed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LED Intellectual Properties, LLC: lead

Study Sites (1)

Nitric Oxide Innovations

Rockdale, Texas, 76567, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Nathan S Bryan, Ph.D.

CONTACT

512-773-9097; drnathanbryan@gmail.com

Chase Marchese

CONTACT

714-924-0492; chase@lightstim.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: August 29, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-06

Locations

US (1)