阻塞性睡眠呼吸暂停(OSA)影响全球接近10亿人,其中美国可能超过8000万成年人受影响,但约80%仍未被诊断。自1981年Colin Sullivan发明持续气道正压(CPAP)设备以来,该设备一直是标准治疗方法,通过面罩在睡眠中保持气道开放。CPAP可显著降低总体死亡率和心血管风险,但依从性问题明显:研究显示治疗3个月后仅38%的患者达到最低使用时长,两年后仅45%被视为“高依从”。未治疗的OSA与高血压、心脏病、中风和痴呆风险上升相关。
低依从性推动替代疗法的发展。定制下颌前移装置(MAD)通过将下颌向前移动减少气道塌陷,在美国价格约1500至4500美元,但主要适用于轻至中度OSA且需要专门牙医配戴。另一种技术是舌下神经刺激,例如Inspire植入设备,已获得FDA批准超过11年,在美国、欧洲和亚洲治疗超过10万名患者。数据显示该疗法可使睡眠呼吸暂停严重程度下降79%,打鼾减少90%,平均每晚使用时间超过6.5小时。研究人员还开发新设备ZeusOSA,通过下巴下的电刺激装置激活舌下神经,并计划进行男女1:1招募的临床试验。
药物疗法也正在出现。2024年,美国FDA批准减重药Zepbound(tirzepatide)用于伴随肥胖的中重度OSA患者,这是首个获得睡眠呼吸暂停适应症的减重药。与此同时,Apnimed开发的夜间口服药通过调节神经肌肉通路稳定上气道,公司已完成两项三期临床试验并计划提交FDA新药申请。尽管创新增加,CPAP仍被认为是最有效治疗之一,因为它直接向气道输送空气。研究显示62%的患者未能达到有效使用水平,因此新的行为干预工具(如获得220万英镑资助的CPAP Buddy应用)正在通过心理和行为支持提高长期依从性。
Obstructive sleep apnea (OSA) affects nearly 1 billion people worldwide, including potentially more than 80 million adults in the United States, of whom about 80% remain undiagnosed. Since Australian physician Colin Sullivan introduced continuous positive airway pressure (CPAP) therapy in 1981, the device has remained the clinical gold standard, using a mask to keep airways open during sleep. CPAP substantially reduces overall mortality and cardiovascular risk, but adherence is limited: studies show that after three months only 38% of patients meet minimum usage requirements, and after two years only 45% are considered highly adherent. Untreated OSA is associated with increased risks of hypertension, heart disease, stroke, and dementia.
Low adherence has driven development of alternative treatments. Custom mandibular advancement devices (MADs) reduce airway collapse by moving the lower jaw forward and cost about $1,500 to $4,500 in the United States, but they mainly treat mild to moderate OSA and require specialized dentists for fitting. Another option is hypoglossal nerve stimulation, including the Inspire implant, which has been FDA approved for more than 11 years and has treated over 100,000 patients across the US, Europe, and Asia. Data show a 79% reduction in sleep apnea severity, a 90% reduction in snoring, and average nightly use exceeding 6.5 hours. Researchers are also developing new devices such as ZeusOSA, which stimulates the hypoglossal nerve through mild electrical pulses under the chin, with an upcoming clinical trial recruiting men and women at a 1:1 ratio.
Pharmaceutical therapies are also emerging. In 2024, the US Food and Drug Administration approved the weight-loss drug Zepbound (tirzepatide) for adults with obesity and moderate to severe OSA, the first obesity drug with a specific sleep apnea indication. Meanwhile, Apnimed has developed a nightly pill targeting neuromuscular pathways that stabilize the upper airway, and the company has completed two phase-three trials and plans to submit a New Drug Application to the FDA this year. Despite these innovations, CPAP remains one of the most effective treatments because it directly delivers air into the airway. Research indicates that 62% of patients do not use CPAP sufficiently for meaningful health benefits, prompting behavioral interventions such as the CPAP Buddy app, which received £2.2 million in funding to improve long-term adherence.