NCT02568761.

Study name	Injection snoreplasty and oropharyngeal exercises: two therapeutic options in the management of snoring and obstructive sleep apnoea syndrome.
Methods	Parallel, RCT.
Participants	Inclusion criteria: 18 years and older; evaluated at the Snoring and Apnea Ambulatory of Hospital de Clinicas de Porto Alegre with clinical complaints related to snoring and sleep apnoea with polysomnography held within 90 days before the inclusion, evidencing index of apnoea/hypopnoea from 0 to 30 events per hour of sleep (snoring, mild and moderate apnoea), without showing desaturation below 90% for time periods longer than 60 minutes; patient without specific prior treatment for snoring and/or apnoea. Exclusion criteria: prior pharyngeal surgery to treat snoring or OSA; BMI higher than 35Kg/m2; nasal or pharyngeal anatomical obstruction higher than 50% of the light; craniofacial deformity; pregnancy; major illnesses associated; ethanol allergy history; absence of a companion to observe the intensity of snoring; patients with no ability to understand the issues (understanding of the proposed procedure and consent form).
Interventions	Intervention: oropharyngeal exercises. Weekly sessions of myofunctional exercises under the supervision of a qualified professional, lasting about 30 minutes each, combined with daily exercises without supervision for a period of 3 months. Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue. Comparator: non‐surgical treatment. Non‐surgical treatment involving the injection of 1.5 mL of 50% ethanol (1 mL of 99.5% ethanol diluted in 1 mL of 2% xylocaine) into the upper palate. 0.5 mL of the solution will be implemented in three different regions of the submucosal layer of the soft palate, one median and two paramedians.
Outcomes	Primary Outcome Measures: Snoring Intensity (measured in decibels). Snoring Index (number of snores per hour of sleep). Secondary Outcome Measures: Sleep quality (PSQI). Sleep quality of the participant room partner (PSQI). Daytime sleepiness (ESS). Measurements: 3 months after treatment.
Starting date	Study Start Date: August 2015. Estimated Study Completion Date: July 2017.
Contact information	Caroline P Royer. Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre.
Notes	Information from ClinicalTrials.gov.