Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
研究概览
简要总结
Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.
41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
详细描述
Since a bidirectional relationship has been suggested for poor sleep and pain and considering that patients suffering from obstructive sleep apnea (OSA) have been reported to present a higher prevalence of temporo-mandibular disorder (TMD) signs and symptoms compared to healthy controls; aims of this research are to detect if an improvement in sleep pattern in patients suffering from OSA, produces a reduction in pain and dysfunction in the orofacial area by examining variation in TMD signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.
41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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 suffering from OSA diagnosed by polysomnography not yet undergoing treatment
排除标准
- •patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination
- •patients presenting dental problems
- •patients assuming medications that would alter pain perception
- •patients not signing the informed consent
研究组 & 干预措施
no treatment
干预措施: no treatment (Other)
treatment
干预措施: osa treatment (Combination Product)
结局指标
主要结局
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
时间窗: change from baseline temporo-mandibular disorders at 18 months
prevalence described as percentage of people having the disease
次要结局
- change in TMD signs according to diagnostic criteria for temporo-mandibular disorder(change from baseline temporo-mandibular disorder signs at 18 months)
- change in TMD symptoms according to diagnostic criteria for temporo-mandibular disorder(change from baseline temporo-mandibular disorder symptoms at 18 months)
研究者
Anna Alessandri Bonetti
Principal Investigator
Catholic University of the Sacred Heart