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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection snoreplasty | Active Comparator | 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. |
|
| Oropharyngeal Exercises | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection Snoreplasty | Procedure | 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. |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline P Royer | Contact | 55 51 3359 8000 | 8314 | carol_persch@hotmail.com |
| Simone C Fagondes | Contact | 55 51 3359 8000 | 8241 |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Lavinsky | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19654581 | Background | Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5. | |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oropharyngeal Exercises | Other | Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue. |
|
| Sleepiness (evaluated with the Epworth Sleepiness Scale) |
| Three months |
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| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |