State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, China.
Sleep Breath. 2023 Dec;27(6):2351-2359. doi: 10.1007/s11325-023-02823-2. Epub 2023 May 22.
CPAP is the "gold standard" treatment for obstructive sleep apnea (OSA). Current CPAP models have developed additional functions including automatic CPAP and pressure relief. However, CPAP adherence has not improved over the last three decades. Many patients in low-income countries cannot afford these CPAP devices. A novel simple CPAP device with a fixed pressure without pressure controller was developed.
Manual CPAP pressure titration was performed in 127 patients with OSA. Six patients with a titration pressure higher than 11 cmHO and 14 patients who could not tolerate CPAP were excluded, leaving 107 participating in the following 2 studies. In study one, 54 of 107 patients were treated by both conventional fixed CPAP and simple CPAP in random order. In the second study, another 53 patients were treated by both autoCPAP in automatic function and simple CPAP in random order. Simple CPAP was fixed at 10 cmHO, 8 cmHO, and 6 cmHO for patients whose titration pressure was between 9-10, 7-8, and ≤ 6 cmHO, respectively. Conventional fixed CPAP device was set exactly the same as manual titration pressure.
All patients whose manual titration pressure ≤ 10 cmHO were effectively treated by simple CPAP (AHI 40.7 ± 2.3 events/h before vs 2.5 ± 0.3 events/h after, p < 0.001). Patients expressed similar preferences for simple CPAP, autoCPAP, and conventional fixed CPAP (p > 0.05).
We conclude that a novel simple CPAP is an alternative treatment for most patients with OSA, which may widen access to CPAP therapy in the developing countries because of its low cost.
CPAP 是阻塞性睡眠呼吸暂停（OSA）的“金标准”治疗方法。目前的 CPAP 模式已经开发出了其他功能，包括自动 CPAP 和压力释放。然而，在过去的三十年中，CPAP 的依从性并没有提高。许多低收入国家的患者都无法负担这些 CPAP 设备。因此，我们开发了一种新型的简单 CPAP 设备，具有固定压力但没有压力控制器。
对 127 例 OSA 患者进行了手动 CPAP 压力滴定。排除了 6 例滴定压力高于 11cmH2O 和 14 例不能耐受 CPAP 的患者，最终有 107 例患者参与了以下两项研究。在第一项研究中，107 例患者中有 54 例随机接受常规固定 CPAP 和简单 CPAP 治疗。在第二项研究中，另外 53 例患者随机接受自动 CPAP 自动功能和简单 CPAP 治疗。对于滴定压力在 9-10、7-8 和≤6cmH2O 之间的患者，简单 CPAP 分别固定在 10cmH2O、8cmH2O 和 6cmH2O。常规固定 CPAP 设备的设置与手动滴定压力完全相同。
所有手动滴定压力≤10cmH2O 的患者均通过简单 CPAP 有效治疗（AHI 从治疗前的 40.7±2.3 次/小时降至治疗后的 2.5±0.3 次/小时，p<0.001）。患者对简单 CPAP、自动 CPAP 和常规固定 CPAP 的偏好相似（p>0.05）。
我们的结论是，新型简单 CPAP 是大多数 OSA 患者的另一种治疗选择，由于其成本低，可能会扩大发展中国家 CPAP 治疗的可及性。
