Snoring
Conditions
Interventions
Forty-five patients with primary snoring, mild or moderate obstructive sleep apnea, who meet the eligibility criteria of the study in question, are included in the study. The study will be conducted a
E02.594
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Instituto de Pesquisas Energéticas e Nucleares - IPEN
Eligibility
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients who present a clinical picture compatible with primary snoring; mild or moderate obstructive sleep apnea with polysomnography (of any type); age group from 25 to 65 years; both sexes and regardless of color or social class; agreement and signing the free informed consent term
Exclusion criteria
Exclusion criteria: Have significant physical obstruction of the nostrils and/or throat observed by the physician with strict indication of surgery and those with laryngeal obstruction; having previously performed surgery in the oropharynx region; patients using more than two antihypertensive drugs or with a previous diagnosis of heart problems; patients using photosensitive medication; presence of lesion in the oropharynx; history of alcohol and/or drug abuse; smoking patients; patients with untreated neurological or psychiatric disorders; patients with craniofacial malformations; pregnant or lactating patients; patients with a BMI above 40kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find the expansion of the lumen of the upper airways (UAS) to pass the airflow of respiration. ;Found outcome 1: the expansion of the lumen of the upper airways (UAS) to pass the airflow of respiration was found. The upper airway lumen was recorded by photographic record of the inside of the mouth and classified according to the modified Mallampati index.Outcome measurements were made through the analysis of data records obtained at the end of treatment and also at the 3 and 6 month follow-up after the end of treatment and compared with data records obtained at baseline. Three independent evaluators, blinded and calibrated for study evaluation, analyze the data collected to evaluate the main outcome (variation of the lumen of the upper airways classified according modified Mallampati index). The process of calibrating the evaluators follows a protocol adapted to the needs of the study, essential to avoid biases in the observation of results. The baseline limit of agreement was set at = 80%. The variation in data (%) obtained between the different moments of the study compared with the baseline measurement was used as the outcome measure and used for statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Found outcome 9: An improvement in sleep quality reported by the patient was found. The questionnaire scores validated for this purpose were used for evaluating this outcome. Self-reported data records obtained at the end of treatment and at the 3- and 6-month follow-up after the end of treatment were compared with data obtained at baseline. The variation in data (%) obtained between the different moments of the study compared with the baseline measurement was used as the outcome measure and used for statistical analysis.;Found outcome 10: A decrease in the perception of snoring reported by the patient was found. The questionnaire scores validated for this purpose were used for evaluating this outcome. Self-reported data records obtained at the end of treatment and at the 3- and 6-month follow-up after the end of treatment were compared with data obtained at baseline. The variation in data (%) obtained between the different moments of the study compared with the baseline measurement was used as the outcome measure and used for statistical analysis.;Expected outcome 2: A decrease in the oxyhemoglobin desaturation index (IDO) is expected. ;Expected outcome 3: It is expected to find a decrease in snoring time during sleep.;Expected outcome 4: It is expected to find a decrease in the peak amplitude of snoring noise (in decibels) during sleep.;Expected outcome 5: It is expected to find an increase in the average oxyhemoglobin saturation value during sleep. ;Expected outcome 6: It is expected to find an increase in the minimum oxyhemoglobin saturation value during sleep. ;Expected outcome 7: It is expected to find a decrease in sleep time with oxyhemoglobin saturation below 90%.;Expected outcome 8: It is expected to find a decrease in daytime sleepiness reported by the patient. ;Expected outcome 9: It is expected to find improvement in sleep quality reported by the patient. ;Expected outcome 10: It is expected to find a decrease in the perception of snoring reported by th | — |
Countries
Brazil
Contacts
Public ContactValeria Mendes
Instituto de Pesquisas Energéticas e Nucleares - IPEN
Outcome results
None listed