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临床试验/NCT00681083
NCT00681083已完成不适用

Titrations Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification

Fisher and Paykel Healthcare4 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年4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
26
试验地点
4
主要终点
Titration Pressures After Treatment Nights

研究概览

简要总结

Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification. It is hypothesised that patients with ThermoSmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).

详细描述

Debate is present concerning the optimal level of humidification for obstructive sleep apnea (OSA) patients who need continuous positive airway pressure (CPAP) therapy. Recent evidence has shown that using a heated breathing tube to increase the amount of humidification that can be delivered has decreased patient side effects, increased subjective sleep quality and decreased subjective symptom scores. Anecdotal evidence exists, in the form of clinical observation, when ThermoSmart® technology is utilized during CPAP titration, patients laboratory titrated pressure may in fact prove to be lower. The possibility exists, on a titration night, patients potentially may experience an adverse response to the positive airway pressure which manifests as increased airway resistance and inflammation necessitating higher CPAP pressures to overcome upper airway resistance and flow limitation. Therefore, we hypothesize the delivery of higher levels of humidity might reduce the nasal airway resistance during the titration night, reducing the overall positive airway pressure requirements. The goal is to investigate this phenomenon to find if a reduction in pressure is necessary and if so to what degree. Patients who are titrated on Continuous Positive Airway Pressure devices with ThermoSmart® technology will have lower titrated pressures than those who are titrated using conventional humidification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Male and Female patients over the age of 18
  • Apnea Hypopnea Index (AHI) ≥15
  • Patients must have at least 5 hours sleep time on each titration night
  • Stable medications for 2 weeks prior to entry to the study and for study inclusion duration including sleep aids

排除标准

  • Receiving or requiring bi-level ventilation
  • Use of a full face interface or chin strap
  • Previous UPPP surgery or palatal reconstruction
  • Recent angina symptoms within 2 weeks of entry
  • CHF with EF < 40%
  • Obesity Hypoventilation Syndrome
  • Cheyne Stokes respiration
  • > 50% Central apneas recorded on diagnostic polysomnogram
  • Supplemental oxygen use
  • Use of narcotic pain medication
  • Hypoxemia as determined by room air pulse oxymetry of less than 89% on room air at rest awake
  • Inability to tolerate positive pressure therapy
  • Split Night Evaluations

研究组 & 干预措施

1

Experimental

Heated breathing tube

干预措施: Heated breathing tube (CPAP with ThermoSmart) (Device)

2

Active Comparator

Non heated breathing tube

干预措施: Non heated breathing tube (CPAP with conventional humidification) (Device)

结局指标

主要结局

Titration Pressures After Treatment Nights

时间窗: End of titration night

Each night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure.

次要结局

  • Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time(End of titration night)

研究者

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

研究点 (4)

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