Injection Snoreplasty and Oropharyngeal Exercises

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.

Conditions
-----------------
Snoring, Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Procedure: Injection Snoreplasty
* Other: Oropharyngeal Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients evaluated at the Snoring and Apnea Ambulatory of Hospital de Clinicas de Porto Alegre with clinical complaints related to snoring and sleep apnea with polysomnography held within 90 days before the inclusion, evidencing index of apnea/hypopnea from 0 to 30 events per hour of sleep (snoring , mild and moderate apnea), without showing desaturation below 90% for time periods longer than 60 minutes. Patient without specific prior treatment for snoring and/or apnea. Exclusion Criteria: Prior pharyngeal surgery to treat snoring or obstructive sleep apnea/hypopnea syndrome (OSAHS). Body mass index above 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection snoreplasty<br>Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml 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. | Procedure: Injection Snoreplasty<br>* Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate.<br>|
| Active Comparator: Oropharyngeal Exercises<br>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 three months. | Other: Oropharyngeal Exercises<br>* Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snoring Intensity (measured in decibels) |  | Three months | 
| Snoring Index (number of snores per hour of sleep) |  | Three months | 
| Upper airway obstruction |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality evaluated with the Pittsburgh Sleep Quality Index |  | Three months | 
| Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index |  | Three months | 
| Sleepiness (evaluated with the Epworth Sleepiness Scale) |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Snoring, Sleep apnea, Obstructive sleep apnea, Speech therapy, Injection snoreplasty, Ethanol, Oropharyngeal exercises