A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Apnea-hypnea-Index (AHI)
研究概览
简要总结
Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer life expectancy and increase in weight in the general population, its prevalence is expected to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at present time. Different oral appliances are available, but most used is the mandibular advancement device (MAD). This study focuses on two different types of MAD: the classic Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to regulate the open space; and the Somnodent, which consists of two separate splints, fixed on the mandible and the maxilla, but has no iron bar attached.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Ability to speak, read, and write Dutch.
- •Ability to follow-up.
- •Ability to use a computer with internet connection for online questionnaires.
- •Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
- •Expected to maintain current lifestyle (sports, medicine, diet, etc.)
排除标准
- •Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
- •Medication used/related to sleeping disorders.
- •Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
- •Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
- •Temporomandibular disorders (based on the function examination of the masticatory system).
- •Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, Periodic Limb Movement Disorder, Narcolepsy).
- •Known medical history of mental retardation, memory disorders, or psychiatric disorders.
- •Reversible morphological upper airway abnormalities (e.g. enlarged tonsils). - Inability to provide informed consent.
- •simultaneous use of other modalities to treat OSA.
- •Previous treatment with a MAD.
结局指标
主要结局
Apnea-hypnea-Index (AHI)
时间窗: 12 months
AHI is measured with polysomnography in hospital
Oxygen-desaturation-Index
时间窗: 12 months
ODI is measured with polysomnography in hospital
次要结局
- Epworth Sleeping Scale(12 months)
- Functional Outcome of Sleep Questionnaire(12 months)
- Euroqol (EQ-5D-3L)(12 months)
- Blood pressure(12 months)
研究者
M.H.T. de Ruiter
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)