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临床试验/ISRCTN51740863
ISRCTN51740863已完成未知

Positional therapy for obstructive sleep apnoea: a randomised controlled trial to assess the effect on health and wellbeing in older and younger people

Royal Brompton & Harefield NHS Foundation Trust0 个研究点目标入组 120 人开始时间: 2019年10月2日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
120

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

性别
All

入选标准

  • 1. Aged > = 18 years
  • 2. Ability and willingness to provide informed consent
  • 3. AHI > 5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep > 20, < 90% of total sleep; central apnoeas < 20% total apnoeas; recording of > = 4 hours of analysable signals
  • 4. Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation

排除标准

  • 1. Unstable cardiac disease
  • 2. Cardiac arrhythmia corrected with an artificial pacemaker
  • 3. Supplemental oxygen
  • 4. Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers
  • 5. Concerns about sleepy driving or any other potentially dangerous symptom from physician
  • 6. BMI > = 40 kg/m2
  • 7. Inability to sleep in a non-supine position
  • 8. Skin sensitivity or an open wound around neck
  • 9. Neck circumference < 12inches (30cm) or > 22inches (55cm)
  • 10. Tics or tremors of the head
  • 11. Sleep with head in upright position
  • 12. A female of child-bearing potential that is pregnant or intends to become pregnant

研究者

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