NCT06678698

Acute Effect of Photobiomodulation in Individuals with Hypertension

Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Universidade Federal de Sao Carlos · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Panel Effective Photobiomodulation Therapy	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
DEVICE	Sham Panel Photobiomodulation Therapy	Use of common red lamp to perform the sham photobiomodulation for the panel group
DEVICE	Modified ILIB Sham Photobiomodulation Therapy	ILIB Therapy device turned off for the sham ILIB therapy
DEVICE	Modified ILIB Photobiomodulation Therapy	Common laser used in ILIB mode for modified ILIB therapy

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2024-11-07
• Last updated: 2024-11-08

Locations

1 site across 1 country: Brazil