Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Polysomnographic efficacy
研究概览
简要总结
In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy.
In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Body Mass Index (BMI) ≤ 35 kg/m²
- •OSAS, as defined by the American Academy of Sleep Medicine Task Force
- •apnea-hypopnea index (AHI) < 50
- •incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion
排除标准
- •Other sleep disorders (i.e. parasomnias)
- •Invasive upper airway surgery for sleep-disordered breathing
- •Known genetic disorders with craniofacial and/or upper airway malformations
- •Use of benzodiazepine and/or antidepressants
- •Known history of psychiatric disease
- •Known history of fibromyalgia and/or chronic fatigue syndrome
- •Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
结局指标
主要结局
Polysomnographic efficacy
时间窗: 3 to 6 months after start of therapy
Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
次要结局
未报告次要终点
研究者
ethisch.comite@uza.be
Ethics Committee Antwerp Univerity Hospital
University Hospital, Antwerp