Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Snoring Intensity (measured in decibels)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Prior pharyngeal surgery to treat snoring or obstructive sleep apnea/hypopnea syndrome (OSAHS).
- •Body mass index above 35Kg / m
- •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).
结局指标
主要结局
Snoring Intensity (measured in decibels)
时间窗: Three months
Snoring Index (number of snores per hour of sleep)
时间窗: Three months
Upper airway obstruction
时间窗: Three months
次要结局
- Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index(Three months)
- Sleep quality evaluated with the Pittsburgh Sleep Quality Index(Three months)
- Sleepiness (evaluated with the Epworth Sleepiness Scale)(Three months)