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临床试验/NCT01137214
NCT01137214撤回2 期

Outcome and Treatment of Complex Sleep Apnea

University of Manitoba1 个研究点 分布在 1 个国家开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Resolution of sleep apnea

研究概览

简要总结

The purpose of the project is:

  1. to determine the incidence of complex sleep apnea
  2. to determine what percentage of cases will resolve over time with therapy with Continuous Positive Airway Pressure
  3. Determine whether there is any difference in outcome, in those with persistent complex sleep apnea on CPAP, between those treated with CPAP or adaptive servo-ventilation.

详细描述

Patients with suspected obstructive sleep apnea (OSA) are studied overnight in a sleep laboratory, as part of their routine clinical management. If they are found to have OSA during the first half of the night, they are started on continuous positive airway pressure (CPAP) by nasal mask as part of their routine clinical management. A certain percentage of these patients (best estimate from the literature 15%) will develop central sleep apnea (CSA) during their treatment with CPAP.

Participants will be recruited from patients treated with Continuous Positive Airway Pressure (CPAP) for obstructive sleep apnea who develop central sleep apnea (CSA) on CPAP, and are willing to give informed consent .

Patients will be treated with the "best CPAP" pressure, as determined by the sleep physician reading their sleep study. This is defined as the minimum pressure associated with elimination of obstructive events. Patients will be treated with CPAP for 12 weeks. Following treatment, patients will be brought back for a second sleep study to be assessed on CPAP.

Those that demonstrate resolution of CSA on the sleep study will continue on CPAP for an additional 12 weeks. Those that demonstrate persistent CSA will be randomized to either "best CPAP" or Adaptive Servo-ventilation (ASV) therapy for an additional 12 weeks. ASV will be titrated during the second sleep study to determine optimal settings. Patients will be compared at the end of 12 and 24 weeks of treatment regarding response to therapy. This will be assessed by compliance with therapy (as monitored by a smart card within the positive pressure machine), improvement in sleepiness as measured by the Epworth Sleepiness Score, and change in quality of life as measured by the Sleep Apnea Quality of Life Index (SAQLI) a validated quality of life instrument specific to sleep apnea.

In addition, in those who demonstrated persistent central apneas after 12 weeks of CPAP therapy, and were randomized to CPAP or ASV, a third and final sleep study will be done to assess the residual apnea-hypopnea index (the number of respiratory events divided by the number of hours of sleep) on therapy. In those randomized to CPAP who have a persistent poor clinical response associated with an abnormal residual AHI after 24 weeks of treatment, a further 12 week trial of ASV will be undertaken to assess whether it offers any benefit.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with obstructive sleep apnea who develop central sleep apnea once treated with CPAP

排除标准

  • Inability to give informed consent, inability to tolerate positive pressure ventilation

结局指标

主要结局

Resolution of sleep apnea

时间窗: 24 weeks

As measured by the apnea-hyponea index

次要结局

  • Quality of life(24 weeks)

研究者

申办方类型
Other

研究点 (1)

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