Injection Snoreplasty and Oropharyngeal Exercises
|ClinicalTrials.gov Identifier: NCT02568761|
Recruitment Status : Unknown
Verified August 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : October 6, 2015
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Snoring Obstructive Sleep Apnea Syndrome||Procedure: Injection Snoreplasty Other: Oropharyngeal Exercises||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||July 2017|
Active Comparator: Injection snoreplasty
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
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.
Active Comparator: 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 three months.
Other: Oropharyngeal Exercises
Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.
- Snoring Intensity (measured in decibels) [ Time Frame: Three months ]
- Snoring Index (number of snores per hour of sleep) [ Time Frame: Three months ]
- Upper airway obstruction [ Time Frame: Three months ]
- Sleep quality evaluated with the Pittsburgh Sleep Quality Index [ Time Frame: Three months ]
- Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index [ Time Frame: Three months ]
- Sleepiness (evaluated with the Epworth Sleepiness Scale) [ Time Frame: Three months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568761
|Contact: Caroline P Royer||55 51 3359 8000 ext firstname.lastname@example.org|
|Contact: Simone C Fagondes||55 51 3359 8000 ext 8241|
|Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande do Sul, Brazil, 90035-903|
|Contact: Caroline P Royer 55 51 3359-8000 ext 8349 email@example.com|
|Contact: Simone C Fagondes 55 51 3359-8000 ext 8241|
|Principal Investigator:||Michelle Lavinsky||Hospital de Clínicas de Porto Alegre|