Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Overall response rate
研究概览
简要总结
Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years
- •severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30
- •patient in failure or refusal of CPAP treatment
- •agree to participate and sign the consent form research
- •speak and understand French without external assistance
- •be in good health (no neurological or psychiatric syndrome).
- •have a valid Social Security card (in France and Portugal only)
排除标准
- •contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
- •dental restorations in progress or planned in the next 6 months
- •psychiatric and neuromuscular disorders
- •untreated cardiovascular diseases and history of stroke or myocardial infarction
- •severe or morbid obesity (body mass index> 35)
研究组 & 干预措施
Narval ORM ® or SomnoDent ®
Mandibular advancement splint (Narval ORM ® or SomnoDent ®)
干预措施: Narval ORM ® or SomnoDent ® (Device)
Somnyx ®
Active mandibular advancement splint (Somnyx ®)
干预措施: Somnyx ® (Device)
结局指标
主要结局
Overall response rate
时间窗: following 3 months of treatment
Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI \<15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night
次要结局
- Sleep quality(Following 3 months of treatment)
- Subjective daytime sleepiness(Following 3 months of treatment)
- Desaturation(Following 3 months of treatment)
- Side effects(Following 3 months of treatment)
- Rate of Complete Response(following 3 months of treatment)
- Quality of life(Following 3 months of treatment)
- Partial response rate(Following 3 months of treatment)
- Subjective compliance(Following 3 months of treatment)
- Subjective sleep(Following 3 months of treatment)
- Fatigue(Following 3 months of treatment)
研究者
Nelly Huynh
Assistant research professor
Université de Montréal