Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05760092
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis xerostomia related to Long-COVID;
* more than 4 weeks after the acute infection hat have persisted for at least 02 months (regardless of whether these patients are already using treatment for the complaints or not);
* Age greater than 18 years.
Exclusion Criteria:
* Clinical diagnosis of other previous rheumatological or musculoskeletal diseases that presents xerostomia;
* Previous use in the last 90 days of laser treatment or other photobiomodulation technique for the same or another indication;
* Clinical manifestations or complaints of xerostomia related to diseases other than Long COVID;
* Previous diseases of the oral or nasal cavity that occur with the symptom of xerostomia;
* Systemic inflammatory diseases (rheumatoid arthritis, Reiter's arthritis, ankylosing spondylitis, generalized polyarthritis, neoplasms);
* Uncontrolled metabolic or endocrine diseases;
* Neoplastic diseases;
* Serious cognitive or psychiatric disorders that that do not allow the understanding of the study;
* Steroid injections during the last 48 hours prior to baseline study assessment;
* Use of corticosteroids at an immunosuppressive dose (20mg daily of prednisone or equivalent for at least 14 days);
* Infection or tumor at the site of therapy application;
* Current chronic infections such as tuberculosis or chronic hepatitis treated or not;
* Severe blood dyscrasia;
* Blood clotting disorders (including thrombosis) at the application site;
* Psychoaffective disorder that prevents adherence to treatment;
* Signs, symptoms or laboratory changes suggestive of acute reinfection by COVID 19;
* Elevated resting heart rate (\>100 beats/min);
* Low or high blood pressure (\<90/60 or \>140/90 mmHg);
* Low blood oxygen saturation (\<95%) at rest, or dyspnea grade 3, 4, or 5 on the Medical Research Council Dyspnea Scale (KOVELIS et al., 2008), or exacerbation of dyspnea on exertion;
* Any condition where exercise is a contraindication such as decompensated heart disease, decompensated diabetes;
* Contraindications to the rehabilitation treatment of post-COVID syndrome recommended by the WHO: presence of heart disease after acute COVID, decrease in blood oxygen saturation after exercise (below 94% or decrease of at least 3% of the baseline saturation), presence of orthostatic hypotension;
* Any photosensitive disease or light sensitivity condition;
* Loss of follow-up at the follow-up clinical outpatient clinic, despite maintaining use of PBM according to the study protocol;
* Pregnancy;
* Any adverse effect on the previous use of PBM.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05760092
Study Brief:
Protocol Section:
NCT05760092