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临床试验/NCT03734341
NCT03734341已完成不适用

A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients

Basque Health Service2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018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
50
试验地点
2
主要终点
Titration pressure

研究概览

简要总结

This study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in CPAP-naïve obstructive sleep apnea patients.

The aim of the study is to verify that this new modality achieves a lower titration pressure.

详细描述

In patients with obstructive sleep apnea (OSA) on CPAP treatment, a CPAP titration test is usually performed to achieve the optimal pressure to maintain upper airway patency, abolish obstructive respiratory events and reduce the occurrence of adverse events. This pressure is called titration pressure.

Until now, we used to perform, after an adaptation period, a single-night outpatient test with an automated device preset on auto-adjusting pressure modality (APAP).

The incremental fixed pressure modality (EZ START) was initially developed to ease patients into having a positive sleep therapy experience from the very beginning. This mode gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. In each good therapy session, the device performs in fixed pressure overnight and we get a real residual apnea-hypopnea index (rAHI).

For this study, we will use the same device (DreamStation auto CPAP, Philips Respironics, Murrysville, PA, USA), a web-based system to telemonitor patient therapy (EncoreAnywhere) and perform for each individual patient the two modalities in a telemonitoring crossover randomized single-blind (patient) way.

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 (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

  • Age 18-80
  • OSA diagnosis
  • CPAP therapy indication

排除标准

  • Previous CPAP therapy
  • Severe COPD
  • Respiratory insufficiency
  • Obesity-hypoventilation syndrome
  • Cardiac failure
  • Recent cerebrovascular disease
  • Central apnea, Cheyne Stokes or similar
  • Important nasal insufficiency or malformation
  • Previous pharyngeal surgery
  • Shift work
  • Psychosocial disability
  • Refusal to participate

研究组 & 干预措施

EZ START Titration

Experimental

CPAP titration test performed with an auto CPAP device preset on incremental fixed pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with EZ START pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period.

Afterwards, the device will be remotely preset on the next modality: auto-adjusting pressure (no wash-out period).

干预措施: EZ START Titration (Device)

EZ START Titration

Experimental

CPAP titration test performed with an auto CPAP device preset on incremental fixed pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with EZ START pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period.

Afterwards, the device will be remotely preset on the next modality: auto-adjusting pressure (no wash-out period).

干预措施: APAP Titration (Device)

APAP Titration

Active Comparator

CPAP titration test performed with an auto CPAP device preset on auto-adjusting pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with APAP pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period.

Afterwards, the device will be remotely preset on the next modality: incremental fixed pressure (no wash-out period).

干预措施: EZ START Titration (Device)

APAP Titration

Active Comparator

CPAP titration test performed with an auto CPAP device preset on auto-adjusting pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with APAP pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period.

Afterwards, the device will be remotely preset on the next modality: incremental fixed pressure (no wash-out period).

干预措施: APAP Titration (Device)

结局指标

主要结局

Titration pressure

时间窗: 14-day maximum period

Titration pressure in any modality

次要结局

  • CPAP Efficacy(14-day period)
  • CPAP Adherence(14-day period)

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mikel Azpiazu

Principal Investigator

Basque Health Service

研究点 (2)

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