Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Marke… (NCT07613671) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma
Brazil60 participantsStarted 2026-07-30
Plain-language summary
Asthma is a chronic inflammatory disease of the airways that results in tissue remodeling, airflow limitation, and bronchial hyperresponsiveness. This study aims to evaluate the long-term effects of photobiomodulation using an LED vest in the management of pediatric asthma. It is a randomized clinical trial involving children aged 6 to 17 years diagnosed with mild to moderate asthma, divided into two groups: an intervention group (using a vest with active LEDs) and a control group (using the vest turned off, simulating the intervention without light emission). The methodology includes clinical and functional assessments such as spirometry, the Asthma Control Test (ACT), the GINA questionnaire, and the Incremental Step Test (IST), which measures exercise tolerance. Photobiomodulation through LEDs promotes cellular biostimulation without thermal effects, modulating inflammatory processes and optimizing tissue regeneration. It is expected that the LED vest will contribute to improving pulmonary function, enhancing quality of life, and complementing conventional treatments. This project aims to advance the clinical application of photobiomodulation as an accessible and effective therapeutic alternative for pediatric asthma.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Critérios de Inclusão: Crianças em idade escolar de 6 a 17 anos Diagnosticado com asma leve a moderada (tratamento farmacológico regular) clinicamente estável Critérios de exclusão:Histórico de exacerbação da asma dentro de 30 dias antes do início do estudo, FAlha no preenchimento dos questionários
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses an LED light vest on children with asthma — can you explain what photobiomodulation actually is, and whether there's existing evidence that it's safe to use on children's chests?
2Since this trial is listed as 'not yet recruiting,' how long do you think it might be before it actually starts enrolling, and would waiting to participate affect my child's current asthma management?
3The trial is measuring functional exercise capacity as its main outcome — does that mean my child would need to do physical exertion tests, and is that safe given their current asthma severity?
4This study is listed as Phase NA, which often applies to device studies — does that mean less is known about the risks compared to a drug trial that has gone through earlier phases, and what does that mean for my child?
5Before considering this trial, should my child first try or complete a standard course of asthma treatment, and would participating in this study fit alongside their existing care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional exercise capacity
Timeframe: From enrollment to the end of treatment at 8 week