A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients
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
- 否
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
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
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
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
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
Mikel Azpiazu
Principal Investigator
Basque Health Service