HypertensionNCT04006158
A Controlled Study to Investigate the Effect of Multi-wave Light Emitting Diode (LED) Bed on Blood Pressure and Endothelial Function
A study testing LED bed in people with Hypertension, run by LED Intellectual Properties, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- LED bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nitric Oxide Innovations
Rockdale, Texas, 76567
Nathan S Bryan, Ph.D., 512-773-9097, drnathanbryan@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- LED bed
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED bedDevice
Low risk FDA cleared full body LED bed
| Study group | Role | What they receive |
|---|---|---|
| LightStim LED Bed | Experimental | Full body LED bed device. Receives: Device: LED bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start29 Aug 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LED Intellectual Properties, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006158
- Sponsor's protocol ID
- Light bed hypertension
- Status last verified
- Jun 2019
- First submitted
- 29 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study to Investigate the Effect of a Multi-wave Light Emitting Diode (LED) Bed on Blood Pressure and Endothelial Function
- ClinicalTrials.gov ID
- NCT04006158
- Acronym / sponsor ID
- Light bed hypertension
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LED Intellectual Properties, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LightStim LED Bed | Experimental | Device: LED bedFull body LED bed device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED bedLow risk FDA cleared full body LED bed | Device | LightStim LED Bed |
Primary outcome
Hypertension
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED bed in people with Hypertension, run by LED Intellectual Properties, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan S Bryan, Ph.D. (512-773-9097, drnathanbryan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.