An interventional study of Panel Effective Photobiomodulation Therapy and Sham Panel Photobiomodulation Therapy in Hypertension, sponsored by Universidade Federal de Sao Carlos. Recruiting at 1 site in Brazil. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Universidade Federal de Sao Carlos · Not applicable, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs
Device: Panel Effective Photobiomodulation Therapy
Participants who will receive full-body photobiomodulation irradiation, with the device turned-off
Device: Sham Panel Photobiomodulation Therapy
Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method
Device: Modified ILIB Photobiomodulation Therapy
Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off
Device: Modified ILIB Sham 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
Use of common red lamp to perform the sham photobiomodulation for the panel group
ILIB Therapy device turned off for the sham ILIB therapy
Common laser used in ILIB mode for modified ILIB therapy
Diastolic Blood Pressure
Diastolic blood pressure measured in millimeters of mercury (mmHg)
Time frame: Acute effect (immediately post-intervention until 24 hours after)
Systolic Blood Pressure
systolic blood pressure measured in millimeters of mercury (mmHg)
Time frame: Acute effect (immediately post-intervention until 24 hours after)
Mean Arterial Pressure
mean arterial pressure measured in millimeters of mercury (mmHg)
Time frame: Acute effect (immediately post-intervention until 24 hours after)
Endothelial Function
Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound
Time frame: Acute effect (About 25 minutes post-intervention)
Arterial Stiffness
Arterial stiffness measured by pulse wave velocity
Time frame: Acute effect (About 15 minutes post-intervention)
Blood Nitrite
Blood nitrite levels
Time frame: Acute effect (1 hour post-intervention)
Plan to share: No
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Universidade Federal de Sao Carlos