Treatment of sleep disorder breathing with tongue stabilizer: a randomized placebo controlled clinical trial

• Grant number: 12/10360-1
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2013
• End date: July 31, 2015
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Lucila Bizari Fernandes Do Prado
• Grantee: Lucila Bizari Fernandes Do Prado
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
• Associated researchers: Aline Jung ; Gilmar Fernandes Do Prado ; Luciane Bizari Coin de Carvalho ; Marco Antonio Cardoso Machado ; Maria Ligia Juliano

Abstract

The Obstructive Sleep Apnea Syndrome (OSAS) is characterized by episodes of complete or partial obstruction of the upper airway during sleep, manifesting as apneas and or hypopneas. Snoring, witnessed apneas, nocturia, "dry mouth" are some of the nocturnal symptoms. Excessive daytime sleepiness, fatigue, weight gain, cognitive and mood disorders, decreased libido, morning headaches are some of the daytime symptoms. According to the polysomnography, the gold standard for diagnosis, OSAS is classified in mild, moderate, and severe, in dependence on apnea and hipopnea index. OSAS is considered risk factor for myocardial and cerebral vascular diseases, and it is involved with the metabolic syndrome. CPAP devices are the gold standard for the treatment for OSAS. They are considered high cost equipments as well the mask for the brasilian population. So the aderence to the treatment is low. One alternative for the treatment of OSAS is the intraoral appliances, which involve low cost and good efficacy and aderence, with studies of level I of evidence supporting their indication, especially in cases of mild to moderate OSA. Most published studies refer to mandibular intraoral repositioning appliances (ARMIOs). Another class of intraoral devices for the same purpose is the Tongue Retainers Devices (TRDs), which appeared in the 80s, with few studies until now. They are used for the treatment of OSAS in edentulous patients, in cases of significant side effects when using ARMIOs or in patients who have not adapted to the use of CPAP for example. The tongue protrusion created by TRDs increases pharyngeal space during sleep apnea patients and modifies the activity of the genioglossus muscle, but has some drawbacks in its use. New variation of TRDs, called Tongue Stabilizing Device (TSD), is more versatile, has smaller volume inside the mouth, it is not necessary to mold of the dental arches (one size), a cost lower than other treatment options and is autoclavable. There are no randomized, controlled and blind trials to verify the results of treatment with this device model. Objective. To assess the efficacy and effectiveness of the DST in the treatment of OSA. Method. Randomized Clinical Trial Cross-Over performed in outpatient Neuro-Sono Sleep Clinic, Discipline of Neurology, UNIFESP. It will be included 74 patients with polysomnographic diagnosis of OSAS, both sex, 25 to 70 years of age. It will be excluded patients taking drugs that modify muscle tone; alcoholics and pregnant women. Patients will be randomized into two groups: study group (SG) will receive the DST and the control group (CG) will receive a placebo device. Patients exchange group after a period of 15 days washout of the first intervention. They will performed polysomnography after 4 weeks of using the active or placebo device, after the period of washout, and after four weeks of the new intervention. Patients will be evaluated before and after each intervention with questionnaires of Quality of Life and Epworth Sleepiness Scale. Patients must to complete a log for daily use of devices and the side effects and device preference will be evaluated. It will be considered treated the patients who show apnea and hypopnea index < 5, improved quality of life and daytime sleepiness. It will be calculated the absolute risk (AR), relative risk (RR) and, Number Needed to Treat (NNT). Taking in account the variable, we will use the Qui-squared test and Student's t test, analysis of variance (ANOVA), and logistic regression model for the interactions among variables. All analyzes will be performed according to intention to treat. We will take the results as significant at p d 0.05. (AU)