Wesper正在改写睡眠呼吸暂停诊断：这种获FDA批准的技术用舒适替代了导管-动脉网

Wesper is Rewriting Sleep Apnea Diagnosis: The FDA-Cleared Tech That Replaces Cannulas with Comfort

CISION 等信源发布 2025-05-16 02:54

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NEW YORK

纽约

，

May 15, 2025

2025年5月15日

/PRNewswire/ -- Studies show that up to 70% of sleep apnea cases may go undiagnosed when home sleep tests rely solely on indirect signals like oxygen desaturation or peripheral arterial tone, rather than

/PRNewswire/ -- 研究表明，当家庭睡眠测试仅依赖于血氧饱和度下降或外周动脉张力等间接信号，而不是直接监测时，多达70%的睡眠呼吸暂停病例可能未被诊断出来。

directly measuring airflo

直接测量气流

[1].

继续阅读

Not all sleep tests are created equal. Wesper goes beyond pulse oximetry with full respiratory analysis, body position tracking, and central apnea detection—giving you clarity where others can't. Unlock airflow. Unlock better care.

并非所有的睡眠测试都是一样的。Wesper超越了脉搏血氧测量，提供全面的呼吸分析、体位追踪和中枢性呼吸暂停检测——在其他人无法做到的地方为您提供清晰的答案。解锁气流。解锁更好的护理。

Small device. Big impact. The Wesper sensor is lightweight, flexible, and designed for comfort—while delivering clinical-grade respiratory insights from the comfort of home.

小巧设备，巨大影响。Wesper传感器轻便、灵活，设计舒适，同时在家就能提供临床级别的呼吸洞察。

Wesper’s full-body insights start here. With easy-to-place patches and wrist-worn pulse oximeter, Wesper captures airflow, body position, and oxygen levels to deliver unmatched accuracy in home sleep testing.

Wesper的全身洞察从这里开始。通过易于放置的贴片和佩戴在手腕上的脉搏血氧仪，Wesper捕捉气流、身体姿势和氧气水平，从而在家庭睡眠测试中提供无与伦比的准确性。

While

虽然

home sleep apnea testing

家庭睡眠呼吸暂停测试

(HSAT) has dramatically improved access to diagnosis, many devices on the market rely on indirect signals—like oxygen desaturation or arterial tone—to infer breathing disturbances. But sleep apnea is a condition defined by disrupted

(HSAT) 已显著改善了诊断的可及性，但市场上的许多设备依赖间接信号（如血氧饱和度下降或动脉张力）来推断呼吸障碍。然而，睡眠呼吸暂停是一种以呼吸中断为特征的疾病。

airflow

气流

. Without capturing this core signal, critical events like hypopneas can be missed, misclassified, or misunderstood. As clinical research and expert consensus increasingly affirm,

如果不捕捉这一核心信号，就可能错过、误判或误解诸如低通气等关键事件。随着临床研究和专家共识的不断确认，

airflow

气流

isn't optional—it's essential.

不是可选的——而是必不可少的。

The

American Academy of Sleep Medicine (AASM)

美国睡眠医学学会 (AASM)

recommends

推荐

airflow

空气流

monitoring as the primary signal for scoring apneas and hypopneas, stating that 'airflow is the most important respiratory signal' for event detection in sleep studies [1]. Without

监测作为评分呼吸暂停和低通气的主要信号，指出“气流是睡眠研究中事件检测最重要的呼吸信号”[1]。没有

airflow

空气流动

, hypopneas are frequently missed, leading to underestimation of sleep apnea severity [2, 3]. Recognizing that the human respiratory system is interconnected with only two degrees of freedom, the AASM determines that using an airflow channel based on two respiratory effort signals is adequate for scoring apnea and hypopnea events..

，低通气事件经常被遗漏，导致睡眠呼吸暂停严重程度的低估 [2, 3]。认识到人体呼吸系统是相互关联且只有两个自由度，AASM 确定使用基于两个呼吸努力信号的气流通道足以对呼吸暂停和低通气事件进行评分。

Wesper Lab

威斯珀实验室

, a Type III HSAT, has developed

，一种III型HSAT，已经开发出来

the first and only

第一个也是唯一一个

FDA-cleared

FDA认证

airflow channel

空气流通道

that is substantially equivalent to a nasal cannula,

这与鼻导管基本上是等效的，

without any facial appliance

没有任何面部设备

。

By using

通过使用

two wearable biosensor patches

两个可穿戴生物传感器贴片

—one on the chest and one on the abdomen—Wesper detects thoracoabdominal movement to compute airflow without requiring a nasal cannula. This approach aligns with gold-standard PSG methods and has been validated by the FDA as substantially equivalent to nasal cannula airflow (

—一个在胸部，一个在腹部—Wesper通过检测胸腹运动来计算气流，而无需使用鼻导管。这种方法与黄金标准的多导睡眠图（PSG）方法一致，并且已被FDA认证为与鼻导管气流测量实质等效（

510k

clearance) [4].

间隙）[4]。

Including airflow offers several clear advantages:

包含气流提供了几个明显的优势：

Improved Diagnostic Accuracy

提高诊断准确性

: Devices without airflow must infer respiratory events from secondary physiological changes, such as blood oxygen desaturation or changes in arterial tone. Studies have shown that

：没有气流的设备必须通过次要的生理变化来推断呼吸事件，例如血氧饱和度下降或动脉张力的变化。研究表明

these methods

这些方法

miss or misclassify events

遗漏或错误分类事件

, especially when desaturation is delayed or absent [5,6]. In contrast,

，特别是当去饱和延迟或缺失时 [5,6]。相反，

Wesper

威斯珀

directly tracks respiratory effort and airflow, improving the sensitivity and specificity of apnea and hypopnea detection [7].

直接跟踪呼吸努力和气流，提高了睡眠呼吸暂停和低通气检测的敏感性和特异性 [7]。

Superior Apnea Type Differentiation

优质的呼吸暂停类型区分

: Distinguishing between

：区分

obstructive sleep apnea

阻塞性睡眠呼吸暂停

(OSA) and

（OSA）和

central sleep apnea

中枢性睡眠呼吸暂停

(CSA) requires knowing whether respiratory effort is present. Surrogate methods face major challenges in effort to reliably make this distinction [8]. Wesper, by simultaneously measuring airflow and effort, can accurately identify central events—essential for guiding appropriate therapy.

(CSA) 的诊断需要了解呼吸努力是否存在。间接方法在可靠地区分这一点上面临重大挑战 [8]。Wesper 通过同时测量气流和呼吸努力，可以准确识别中枢性事件——这对于指导适当的治疗至关重要。

Better Patient Comfort and Compliance

更好的患者舒适度和依从性

: Nasal cannulas are often poorly tolerated at home, leading to dislodgement or incomplete studies and inaccurate readings. Wesper eliminates the need for facial sensors, offering a

鼻导管在家中常常难以忍受，导致移位或研究不完整以及读数不准确。Wesper消除了对面部传感器的需求，提供了一种解决方案。

more comfortable, reliable and user-friendly setup

更加舒适、可靠和用户友好的设置

that encourages adherence and supports

鼓励坚持并支持

multi-night testing

多夜测试

。

Resilience to External Factors

外部因素的适应力

: Peripheral signal-based devices (e.g., PAT/PPG) can be disrupted by cold extremities, poor circulation, and arrhythmias such as

：基于外周信号的设备（例如，PAT/PPG）可能会因四肢冰冷、血液循环不良和心律不齐等情况而受到干扰，

atrial fibrillation

心房颤动

. Wesper is immune to these issues because it measures respiratory motion directly from the thorax and abdomen [9,10].

Wesper不受这些问题的影响，因为它直接从胸部和腹部测量呼吸运动[9,10]。

Wesper's FDA-cleared, cannula-free airflow technology represents a pivotal advancement in home sleep testing—combining clinical precision with patient comfort.

Wesper的经FDA认证、无需插管的气流技术代表了家庭睡眠测试的关键进步——结合了临床精度与患者舒适度。

Unlike other systems that rely on surrogates or disposable gadgets, Wesper delivers accurate,

与其他依赖替代品或一次性小工具的系统不同，Wesper 提供了准确的结果，

multi-night

多夜

, reusable testing that aligns with gold-standard PSG outcomes and fits modern care workflows.

，符合黄金标准PSG结果并适应现代护理工作流程的可重复测试。

With rising demand for sleep diagnostics and growing awareness of apnea's impact on

随着对睡眠诊断的需求不断增加，以及对呼吸暂停影响的认识不断提高，

chronic disease

慢性病

, airflow-based HSAT isn't just a better choice—it's the new clinical imperative.

，基于气流的 HSAT 不仅仅是一个更好的选择——它是新的临床需求。

About Wesper

关于Wesper

Wesper is a leading provider of advanced home sleep testing solutions, delivering clinically validated, multi-night diagnostics and titration with unparalleled comfort and accuracy. With a 99% patient success rate and seamless provider integration, Wesper is redefining the future of sleep care—accessible, precise, and built for long-term outcomes..

Wesper 是一家领先的先进家庭睡眠测试解决方案提供商，提供临床验证的多夜诊断和调试，具有无与伦比的舒适性和准确性。凭借 99% 的患者成功率和无缝的供应商整合，Wesper 正在重新定义睡眠护理的未来——可及、精准，并致力于长期效果。

References

参考文献

Vishesh KK, et al. J Clin Sleep Med. 2017;13(3):479-504.

Vishesh KK, 等。《临床睡眠医学杂志》。2017年；13(3):479-504。

Ruehland WR, et al.

Ruehland WR, 等。

Sleep.

睡眠。

2009;32(2):150–157.

2009；32（2）：150–157。

Shamim-Uzzaman QA, et al. Sleep Sci Pract. 2018;2:7.