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临床试验/NL-OMON45035
NL-OMON45035已完成不适用

A comparison between two different oral appliance therapies: Somnodent vs Herbst appliance in patients with mild and moderate OSA; a Randomised Controlled Trial - COSH (comparison OSA patients Somnodent vs Herbst)

Academisch Medisch Centrum0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

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, PLMS, 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.

研究者

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