Injection Snoreplasty and Oropharyngeal Exercises

Overview

A randomized single blind clinical trial, with a larger sample size than previous studies , to evaluate the effectiveness of injection snoreplasty in the treatment of patients with snoring and obstructive sleep apnea/hypopnea syndrome (OSAHS) compared to oropharyngeal exercises, a low cost therapeutic modality.

34 patients will be randomly allocated into two groups. One group will be submitted to injection snoreplasty and another group will be submitted to daily sessions of oropharyngeal exercises. Researchers involved in interventions will not participate in the outcomes evaluation and researchers responsible for the assessment of outcomes will be blinded to the tested therapeutic modalities. All patients will be evaluated at a pre-intervention visit, when will be collected objective data and carried out a complete otorhinolaryngological exam. Patients will fill validated specific questionnaires for evaluation of snoring, apnea, daytime sleepiness, fatigue, presence of systemic arterial hypertension and sleep quality. The quality of sleep of the patients bedroom companions will be also evaluated. Patients will be randomized only after these evaluations. All patients included in the study will be submitted to a portable sleep study. Simultaneously, the objective assessment of snoring will be held, covering the analysis of snoring intensity (measured in decibels) and the snoring index (number of snores per hour of sleep). Patients allocated to group A will receive injection snoreplasty. Patient returns will be weekly, until the complete healing of the palate. After four weeks of treatment, the bedroom companion will be asked about whether the snoring remains a problem, and if so, the procedure is repeated, with each patient receiving up to three applications. At the end of three months, all evaluations will be repeated and the data obtained will be compared to baseline data. Patients allocated at group B will be evaluated by a speech therapist. Patients will undergo weekly oropharyngeal exercises sessions under supervision, lasting about 30 minutes each, and will be instructed to perform the exercises daily at home, for a period of three months. At the end of this period, patients will be re-evaluated and the initial data will be compared to the obtained final data.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts