Recruiting

LED Bed

Sponsor:

LED Intellectual Properties, LLC

Code:

NCT04006158

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LED bed

Study Details

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

Study ID

NCT04006158

Start date

Aug 29, 2018

Status verified date

Jun, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LightStim LED Bed

Full body LED bed device.

Interventions

LED bed

Low risk FDA cleared full body LED bed

Primary outcome measure

  • Hypertension [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Nathan S Bryan, Ph.D.

512-773-9097drnathanbryan@gmail.com

Chase Marchese

714-924-0492chase@lightstim.com

Locations

Nitric Oxide Innovations

Recruiting

Rockdale, Texas, United States, 76567

Contacts

Nathan S Bryan, Ph.D.

512-773-9097drnathanbryan@gmail.com

More Information

Sponsor

LED Intellectual Properties, LLC

Last update posted

Jul 5, 2019

Last verified

Jun, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LED Intellectual Properties, LLC on 2019-07-05.