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临床试验/ACTRN12615000122550
ACTRN12615000122550已完成未知

An observational study comparing neurocognitive function of obese patients with sleep disordered breathing with and without chronically elevated arterial carbon dioxide levels before and after 3 months of positive pressure mask therapy.

Sheila Sivam0 个研究点目标入组 60 人开始时间: 2015年2月11日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • 1.Age 18 – 75 years old
  • 2.Written informed consent
  • 3.Daytime CO2 > 45 (OHS) or < 45 (Control)
  • 4.Evidence of definite OSA on polysomnography, with an AHI >20 /hr OR evidence of sleep hypoventilation if AHI <20/hr
  • *Increase in TcCO2 to a value > 55mmHg for >10 mins or
  • *Increase in TcCO2 > 10 mmHg (compared with awake PaCO2) to a value > 50 mmHg for > 10 mins)
  • 5.BMI>40kg/m2
  • 6.pH is in the normal range for chronic hypercapnia
  • 7.FEV1/FVC ratio > 0.7

排除标准

  • 1.Major psychiatric, neurological disorder or head injury
  • 2.Neuromuscular disease or lung disease
  • 3.FEV1/FVC ratio <0.7
  • 4.Uncontrolled medical conditions including cardiac failure
  • 5.Alcohol consumption >30 g/day or on medications potentially affecting cognitive testing or EEG recordings such as opiates, benzodiazepines, anti-depressants and anticonvulsants (unless on stable low dose).
  • 6.Not proficient in English

研究者

发起方
Sheila Sivam

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