HypertensionNCT06678698
Acute Effect of Photobiomodulation in Individuals with Hypertension
A study testing Panel Effective Photobiomodulation Therapy and Modified ILIB Photobiomodulation Therapy in people with Hypertension, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
This is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (PBM) and modified ILIB (Intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Panel Effective Photobiomodulation Therapy and Modified ILIB Photobiomodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sedentary or irregularly inactive individuals (IPAQ)
- Both sexes
- Age between 40 to 60 years old
- Clinical diagnosis of hypertension for at least 3 months with difficulty in blood pressure control
- Hypertension classification up to stage 2
- Individuals who have a prescription for hypertension control drugs and have been using these drugs for at least 3 months
Who cannot join
- Diabetes diagnosis
- Smokers
- BMI > 30 kg/m²
- Cardiac pacemaker use
- Presence of arrhythmias or other decompensated cardiovascular diseases
- Musculoskeletal, orthopedic or neurological conditions that make it unable to participate in the procedures
Show all 13Show fewer
- Presence of cognitive deficits that make it difficult to understand the assessments
- Presence of active neoplasia, under suspicion or after 5 years in remission period
- Presence of tattoos (covering a large body area, or the anterior wrist region)
- Photosensitive drugs use
- Pregnant women or under suspicion
- Presence of epilepsy or seizures
- Participants who present a systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg on the day of the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of São Carlos
São Carlos, São Paulo, 13565-905
Lara Espósito, PT, +551633518985, larabataglia@estudante.ufscar.br
About this study
Official title: Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
This is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (PBM) and modified ILIB (Intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. Participants (n=48) will be equally, randomly and secretly allocated into one of 4 groups: Panel Group; Panel Sham Group; Modified ILIB group; and Modified ILIB Sham Group. Participants aged 40 to 60 years old, diagnosed with hypertension and using control drugs for at least 3 months will be included. Participants will be assessed at pre- and post-intervention for: BP; endothelial function; arterial stiffness; blood nitrite; and thermography. In the post-intervention period, the ambulatory blood pressure monitoring will also be carried out. Participants will receive a single application of PBM, which, depending on the group, may be full-body irradiation from an LED panel (660 nm; 25.34 J/cm²; 42.24 mW/cm²), modified ILIB (660 nm; 42,462 J/cm²; 35.385 W/cm²), or the respective sham therapies. Data homogeneity and normality will be verified by the Levene and Shapiro-Wilk tests, which will determine the choice of subsequent tests. A statistical significance of 5% will be considered.
- Conditions
- Hypertension
- Being tested
- Panel Effective Photobiomodulation Therapy, Sham Panel Photobiomodulation Therapy, Modified ILIB Sham Photobiomodulation Therapy, Modified ILIB Photobiomodulation Therapy
- Keywords
- hypertension, photobiomodulation, low-level light therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panel Effective Photobiomodulation TherapyDevice
Photobiomodulation therapy is the use of low-power light in biological tissues through a non-ionizing source of light (600 to 1.100 nm), with variable power between 1 and 500 mW and therapeutic goals.
This group will receive photobiomodulation from a whole-body panel of low intensity LEDs
Sham Panel Photobiomodulation TherapyDevice
Use of common red lamp to perform the sham photobiomodulation for the panel group
Modified ILIB Sham Photobiomodulation TherapyDevice
ILIB Therapy device turned off for the sham ILIB therapy
Modified ILIB Photobiomodulation TherapyDevice
Common laser used in ILIB mode for modified ILIB therapy
| Study group | Role | What they receive |
|---|---|---|
| Panel Group | Experimental | Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs Receives: Device: Panel Effective Photobiomodulation Therapy |
| Panel Sham Group | Sham comparator | Participants who will receive full-body photobiomodulation irradiation, with the device turned-off Receives: Device: Sham Panel Photobiomodulation Therapy |
| Modified ILIB Group | Experimental | Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method Receives: Device: Modified ILIB Photobiomodulation Therapy |
| Modified ILIB Sham Group | Sham comparator | Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off Receives: Device: Modified ILIB Sham Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic Blood Pressure
Diastolic blood pressure measured in millimeters of mercury (mmHg)
Measured: Acute effect (immediately post-intervention until 24 hours after)
Secondary outcomes (5)
Systolic Blood Pressure
systolic blood pressure measured in millimeters of mercury (mmHg)
Measured: Acute effect (immediately post-intervention until 24 hours after)
Mean Arterial Pressure
mean arterial pressure measured in millimeters of mercury (mmHg)
Measured: Acute effect (immediately post-intervention until 24 hours after)
Endothelial Function
Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound
Measured: Acute effect (About 25 minutes post-intervention)
Arterial Stiffness
Arterial stiffness measured by pulse wave velocity
Measured: Acute effect (About 15 minutes post-intervention)
Blood Nitrite
Blood nitrite levels
Measured: Acute effect (1 hour post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 May 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (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
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Lara Maria Bataglia Espósito, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678698
- Sponsor's protocol ID
- UFSaoCarlosPBM
- Status last verified
- Nov 2024
- First submitted
- 13 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06678698
- Acronym / sponsor ID
- UFSaoCarlosPBM
- Conditions
- Hypertension
- Keywords
- hypertension, photobiomodulation, low-level light therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
This is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (PBM) and modified ILIB (Intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. Participants (n=48) will be equally, randomly and secretly allocated into one of 4 groups: Panel Group; Panel Sham Group; Modified ILIB group; and Modified ILIB Sham Group. Participants aged 40 to 60 years old, diagnosed with hypertension and using control drugs for at least 3 months will be included. Participants will be assessed at pre- and post-intervention for: BP; endothelial function; arterial stiffness; blood nitrite; and thermography. In the post-intervention period, the ambulatory blood pressure monitoring will also be carried out. Participants will receive a single application of PBM, which, depending on the group, may be full-body irradiation from an LED panel (660 nm; 25.34 J/cm²; 42.24 mW/cm²), modified ILIB (660 nm; 42,462 J/cm²; 35.385 W/cm²), or the respective sham therapies. Data homogeneity and normality will be verified by the Levene and Shapiro-Wilk tests, which will determine the choice of subsequent tests. A statistical significance of 5% will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel Group | Experimental | Device: Panel Effective Photobiomodulation TherapyParticipants who will receive full-body photobiomodulation irradiation, from a panel of LEDs |
| Panel Sham Group | Sham comparator | Device: Sham Panel Photobiomodulation TherapyParticipants who will receive full-body photobiomodulation irradiation, with the device turned-off |
| Modified ILIB Group | Experimental | Device: Modified ILIB Photobiomodulation TherapyParticipants who will receive photobiomodulation irradiation with the transcutaneous ILIB method |
| Modified ILIB Sham Group | Sham comparator | Device: Modified ILIB Sham Photobiomodulation TherapyParticipants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sedentary or irregularly inactive individuals (IPAQ)
- Both sexes
- Age between 40 to 60 years old
- Clinical diagnosis of hypertension for at least 3 months with difficulty in blood pressure control
- Hypertension classification up to stage 2
Key exclusion criteria (13 listed)
- Diabetes diagnosis
- Smokers
- BMI > 30 kg/m²
- Cardiac pacemaker use
- Presence of arrhythmias or other decompensated cardiovascular diseases
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 |
|---|---|---|
| Panel Effective Photobiomodulation TherapyPhotobiomodulation therapy is the use of low-power light in biological tissues through a non-ionizing source of light (600 to 1.100 nm), with variable power between 1 and 500 mW and therapeutic goals. This group will receive photobiomodulation from a whole-body panel of low intensity LEDs | Device | Panel Group |
| Sham Panel Photobiomodulation TherapyUse of common red lamp to perform the sham photobiomodulation for the panel group | Device | Panel Sham Group |
| Modified ILIB Sham Photobiomodulation TherapyILIB Therapy device turned off for the sham ILIB therapy | Device | Modified ILIB Sham Group |
| Modified ILIB Photobiomodulation TherapyCommon laser used in ILIB mode for modified ILIB therapy | Device | Modified ILIB Group |
Primary outcome
Diastolic Blood Pressure
Time frame: Acute effect (immediately post-intervention until 24 hours after)
Diastolic blood pressure measured in millimeters of mercury (mmHg)
5 secondary outcomes
Systolic Blood Pressure
Time frame: Acute effect (immediately post-intervention until 24 hours after)
Mean Arterial Pressure
Time frame: Acute effect (immediately post-intervention until 24 hours after)
Endothelial Function
Time frame: Acute effect (About 25 minutes post-intervention)
Arterial Stiffness
Time frame: Acute effect (About 15 minutes post-intervention)
Blood Nitrite
Time frame: Acute effect (1 hour post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panel Effective Photobiomodulation Therapy and Modified ILIB Photobiomodulation Therapy in people with Hypertension, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic Blood Pressure (time frame: Acute effect (immediately post-intervention until 24 hours after)). 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 8 Nov 2024.