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临床试验/NCT00750165
NCT00750165已完成不适用

Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.

Fisher and Paykel Healthcare1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2007年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Apnea Hypopnea Index (AHI)

研究概览

简要总结

Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •AHI >15 on the diagnostic portion of the study
  • •>18 years of age

排除标准

  • •Significant Central Apnea
  • •Congestive Heart Failure
  • •Inability to give informed consent
  • •Patient intolerance to CPAP
  • •Anatomical or physiological conditions making CPAP therapy inappropriate

研究组 & 干预措施

Titration Night

Experimental

Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device

干预措施: SleepStyle 200 Auto Series CPAP Humidifier (Device)

结局指标

主要结局

Apnea Hypopnea Index (AHI)

时间窗: 1 night

The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.

次要结局

  • Arousal Index (AI)(1 Night)
  • Respiratory Disturbance Index (RDI)(1 Night)
  • Percent of Time With Less Than 90% Oxygen Saturation(1 Night)

研究者

发起方
Fisher and Paykel Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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