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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LightStim LED Bed | Experimental | Full body LED bed device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LED bed | Device | Low risk FDA cleared full body LED bed |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathan S Bryan, Ph.D. | Contact | 512-773-9097 | drnathanbryan@gmail.com | |
| Chase Marchese | Contact | 714-924-0492 | chase@lightstim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nitric Oxide Innovations | Recruiting | Rockdale | Texas | 76567 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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