RCT of the Effect of Uvulopalatopharyngoplasty Compared to Expectancy in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Changes in apnea-hypopnea index
研究概览
简要总结
Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6 months in patients with OSAS.
Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can elevate the risk for traffic accidents. Increased morbidity and three to four times increased mortality in these patients are well documented, mainly in the cardiovascular field. Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was the predominant treatment for OSAS worldwide before continuous positive airway pressure (CPAP) devices became widely available in the 1990s. Since then, the main treatment for OSAS has been CPAP, but an increasing number of patients are also treated with mandibular retaining device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The evidence-grade for the efficacy has so far been very low, and the side-effects and complication rate has raised the question whether there is a place for surgical treatment of OSAS. However, the compliance for CPAP and dental devices are quite low (50-60%), leaving a lot of patients untreated if surgery is not offered. RCT UPPP is still missing and called for.
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
- •ApnéHypopnéIndex, AHI >14,9 Daytime sleepiness w Epworth sleepiness scale, ESS> 7 Sleepy during daytime 3-5 times per week or more BodyMassIndex, BMI < 36,0 Friedman staging system of tonsil size and tongue: i and II Patients w Friedman stage I and BMI < 30,0 could be directly included if patient positive and no contra-indications for surgery. All others should be failure of CPAP and MRD before inclusion.
排除标准
- •Other OSAS treatment during study, i.e., patient is clinically severely deteriorated.
- •Negative to surgery Night-shift worker Friedman stage III or IV Morbid obesity BMI >35,9 Severe psychological or neurological disease ASA class >3 Severe lung- or heart disease (not applicable for hypertension, nor stroke or MI more than after 2 years).
- •Insufficient knowledge in Swedish language (important for filling in questionnaires) Dangerous in traffic while driving Severe nasal congestion (can be included after successful treatment) Previous tonsillectomy
研究组 & 干预措施
Uvulopalatopharyngoplasty
One arm is Uvulopalatopharyngoplasty(intervention group of 32 patients), one arm is expectancy (control group of 33 patients). After six months the controls have delayed surgery and then both groups are followed for two years
干预措施: Uvulopalatopharyngoplasty (Procedure)
Control
After six months the controls have delayed surgery then are followed for 2 year
干预措施: Uvulopalatopharyngoplasty (Procedure)
结局指标
主要结局
Changes in apnea-hypopnea index
时间窗: 6 months and 2 years
Apnea-hypopnea index (AHI) is the number of apneas or hypopneas per sleep hour. Polysomnography (PSG) is the Golden standard to use when measuring the AHI. PSG is the method we are using
次要结局
- Changes in Epworth sleepiness scale(6 months and 2 years)
研究者
Danielle Friberg
Associate Professor, MD, Senior Surgeon
Karolinska University Hospital