NCT06678698 Acute Effect of Photobiomodulation in Individuals with Hypertension
| NCT ID | NCT06678698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Federal de Sao Carlos |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-05-01 with a primary completion date of 2025-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Frequently Asked Questions
Who can join the NCT06678698 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 60 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678698 currently recruiting?
Yes, NCT06678698 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universidade Federal de Sao Carlos to inquire about joining.
Where is the NCT06678698 trial being conducted?
This trial is being conducted at São Carlos, Brazil.
Who is sponsoring the NCT06678698 clinical trial?
NCT06678698 is sponsored by Universidade Federal de Sao Carlos. The trial plans to enroll 48 participants.