Sleep Apnea, Obstructive
Conditions
Interventions
This is a randomized, controlled, double-blind, parallel-arm clinical trial. Participants (men and women between 25 and 65 years of age, regardless of race or social class, with sleep-disordered breat
E02.594
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Sistema Nacional de Laboratórios de Fotônica
Beauty Smile, Clinica Dental Laser
Eligibility
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women; aged between 25 and 65 years; regardless of race or social class; who are at risk of obstructive sleep apnea by screening with the Stopbang questionnaire; with a minimum wash out of six months for other therapies for sleep-disordered breathing; who agree to participate in the study with signature of the free and informed consent form
Exclusion criteria
Exclusion criteria: Undergoing medical treatment or treatment for sleep-related breathing disorders; smokers; alcoholics; cancer patients; with diagnosed lung problems; with heart disease; using more than two antihypertensive drugs; with pharyngeal or nasal obstructions that require strictly surgical resolution; with previous surgery in the oropharynx region; pregnant or lactating women; history of photosensitivity (allergies); using photosensitive medication; Body mass index (BMI) above 40 kg/m2; participants who are unable to attend treatment sessions or follow-up appointments; or who do not perform follow-up exams as indicated by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As the main outcome, we will evaluate the variation in the oxyhemoglobin desaturation index. The oxyhemoglobin desaturation index reflects the number of obstructive events per hour of sleep. The lower the value of the index, the better the patient's health status | — |
Secondary
| Measure | Time frame |
|---|---|
| The variation in sleep time with snoring that is positively related to the severity of the respiratory disorder (the noise is a consequence of the respiratory effort to overcome the imposed tissue resistance);The variation in the peak amplitude of the snoring noise that is positively related to the severity of the respiratory disorder (the noise is a consequence of the respiratory effort to overcome the imposed tissue resistance);Variation in spectral analysis of potential biomarkers for obstructive sleep apnea (OSA). Spectral analysis of potential biomarkers for obstructive sleep apnea is not yet well established in the literature, but there is evidence that alpha-amylase may be more pronounced after a night with many respiratory obstruction events;Score variation of the Stopbang questionnaire for screening for risk of obstructive sleep apnea;Variation in Epworth Daytime Sleepiness Perception Questionnaire Score;The variation in upper airway lumen according to the modified Mallampati Classification. The upper airway lumen is a predictor of severity for obstructive sleep apnea (OSA). The smaller the lumen for the passage of breathing air, the greater the risk for obstructive sleep apnea | — |
Countries
Brazil
Contacts
Public ContactValeria Mendes
Instituto de Pesquisas Energéticas e Nucleares - IPEN
Outcome results
None listed