Asthma (Diagnosis)Asthma PBMNCT07613671
Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma
A study testing Photobiomodulation and Exercise in people with Asthma (Diagnosis), run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Photobiomodulation and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Uninove
São Paulo, São Paulo, 01525000
Luciana M Sampaio, Dra, +55011996002075, lucianamalosa@gmail.com
About this study
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.
Read the detailed description
Asthma is a chronic inflammatory disease characterized by airway hyperresponsiveness, persistent inflammation, airflow limitation, and structural airway remodeling. Pediatric asthma remains a major public health concern due to its impact on lung development, exercise tolerance, quality of life, and healthcare utilization. Despite advances in pharmacological therapies, many children continue to experience symptoms, exacerbations, and functional limitations, highlighting the need for complementary therapeutic strategies.
Photobiomodulation therapy (PBMT) has emerged as a promising non-invasive intervention capable of modulating biological processes through light energy absorption by cellular photoreceptors. By stimulating mitochondrial activity and enhancing ATP production, PBMT may reduce inflammatory responses, improve tissue repair, and optimize microcirculatory function without inducing thermal damage. Experimental studies have demonstrated anti-inflammatory effects associated with reductions in pro-inflammatory cytokines and oxidative stress markers.
This randomized clinical trial aims to investigate the chronic effects of an LED vest-based photobiomodulation intervention on functional capacity, inflammatory markers, and pulmonary outcomes in children aged 6-17 years diagnosed with mild to moderate asthma. Participants will be randomly assigned to either an intervention group receiving active LED treatment or a control group receiving sham treatment through an inactive vest. Clinical and functional assessments will include spirometry, Asthma Control Test (ACT), GINA assessment, and the Incremental Step Test (IST) to evaluate exercise tolerance. Additional physiological parameters may be analyzed to investigate underlying mechanisms associated with treatment response.
The findings of this study may contribute to the development of innovative, accessible, and clinically applicable therapeutic strategies for pediatric asthma management.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Photobiomodulation, Exercise
- Keywords
- pediatric asthma, Photobiomodulation Therapy, Pulmonary Function, Inflammatory Biomarkers, Low-Level Light Therapy (LLLT), asthma
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
- Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature.
Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator.
ExerciseOther
Supervised Physical Training:
The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation and exercise | Experimental | 20 minutes using PTBM after 30 minutes making aerobic exercise Receives: Other: Photobiomodulation |
| Exercise | Sham comparator | 30 minutes making aerobic exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Oxugen consumption measured during cardiopulmonary testing
Measured: From enrollment to the end of treatment at 8 week
Secondary outcomes (3)
FVC
lung function- forced vital capacity
Measured: From enrollment to the end of treatment at 8 week
FEV1
lung function- expiratory volume in 1 second
Measured: From enrollment to the end of treatment at 8 week
Global Initiative for Asthma
score
Measured: From enrollment to the end of treatment at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
- Investigators
- Luciana M Sampaio, Dra, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613671
- Sponsor's protocol ID
- Asthma and photobiomodulation
- Acronym
- Asthma PBM
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma
- ClinicalTrials.gov ID
- NCT07613671
- Acronym / sponsor ID
- Asthma PBM / Asthma and photobiomodulation
- Conditions
- Asthma (Diagnosis)
- Keywords
- pediatric asthma, Photobiomodulation Therapy, Pulmonary Function, Inflammatory Biomarkers, Low-Level Light Therapy (LLLT), asthma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma is a chronic inflammatory disease characterized by airway hyperresponsiveness, persistent inflammation, airflow limitation, and structural airway remodeling. Pediatric asthma remains a major public health concern due to its impact on lung development, exercise tolerance, quality of life, and healthcare utilization. Despite advances in pharmacological therapies, many children continue to experience symptoms, exacerbations, and functional limitations, highlighting the need for complementary therapeutic strategies.
Photobiomodulation therapy (PBMT) has emerged as a promising non-invasive intervention capable of modulating biological processes through light energy absorption by cellular photoreceptors. By stimulating mitochondrial activity and enhancing ATP production, PBMT may reduce inflammatory responses, improve tissue repair, and optimize microcirculatory function without inducing thermal damage. Experimental studies have demonstrated anti-inflammatory effects associated with reductions in pro-inflammatory cytokines and oxidative stress markers.
This randomized clinical trial aims to investigate the chronic effects of an LED vest-based photobiomodulation intervention on functional capacity, inflammatory markers, and pulmonary outcomes in children aged 6-17 years diagnosed with mild to moderate asthma. Participants will be randomly assigned to either an intervention group receiving active LED treatment or a control group receiving sham treatment through an inactive vest. Clinical and functional assessments will include spirometry, Asthma Control Test (ACT), GINA assessment, and the Incremental Step Test (IST) to evaluate exercise tolerance. Additional physiological parameters may be analyzed to investigate underlying mechanisms associated with treatment response.
The findings of this study may contribute to the development of innovative, accessible, and clinically applicable therapeutic strategies for pediatric asthma management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation and exercise | Experimental | Other: Photobiomodulation20 minutes using PTBM after 30 minutes making aerobic exercise |
| Exercise | Sham comparator | Other: Exercise30 minutes making aerobic exercise |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation1. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator. | Other | Photobiomodulation and exercise |
| ExerciseSupervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring. | Other | Exercise |
Primary outcome
Functional exercise capacity
Time frame: From enrollment to the end of treatment at 8 week
Oxugen consumption measured during cardiopulmonary testing
3 secondary outcomes
FVC
Time frame: From enrollment to the end of treatment at 8 week
FEV1
Time frame: From enrollment to the end of treatment at 8 week
Global Initiative for Asthma
Time frame: From enrollment to the end of treatment at 8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luciana M Sampaio, Dra principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and Exercise in people with Asthma (Diagnosis), run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciana M Sampaio, Dra (+55011996002075, lucianamalosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: From enrollment to the end of treatment at 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.