Testing a Light Therapy Device for People With High Blood Pressure
Tests light therapy, compared with sham, in adults aged 40 to 60 with hypertension.
Plain-language title generated from the registry record
Registry title: Acute Effect of Photobiomodulation in Individuals with Hypertension
Key facts
- Where
- São Carlos, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 60 years old?
Source: NCT06678698, who can take part
Where in Brazil
- Federal University of São CarlosSão Carlos, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universidade Federal de Sao Carlos
- Trial code
- NCT06678698
- Record updated
- 8 November 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Photosensitive drugs use; Diabetes diagnosis; 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 epilepsy or seizures; Smokers; BMI > 30 kg/m²; 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); Pregnant women or under suspicion; Participants who present a systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg on the day of the intervention.