振动触觉体位疗法治疗体位阻塞性睡眠呼吸暂停：一项多中心随机对照试验

IF 7.7 1区医学 Q1 RESPIRATORY SYSTEM

Thorax Pub Date : 2025-09-24 DOI:10.1136/thorax-2024-222681

Julia L Kelly, Chris D Turnbull, Roger Newson, Melissa Dobson, Emma L Hedley, Abdullah S ALQarni, Ann Nevinson, David Dawson, Annabel Nickol, Sophie West, Nick P Talbot, Najib M Rahman, John Stradling, Mary J Morrell

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引用次数: 0

摘要

新一代体位治疗装置为体位阻塞性睡眠呼吸暂停（POSA）患者提供振动触觉反馈，减少仰卧睡眠时间，降低睡眠呼吸暂停严重程度。对POSA严重程度、嗜睡和生活质量（QoL）的长期影响尚不清楚。方法一项随机、平行、双盲试验比较颈戴体位疗法和假体位疗法3个月的疗效（ClinicalTrials.gov: [NCT04153240][1]）。POSA成年患者（呼吸暂停/呼吸不足指数（AHI） bb50次/小时，仰卧位与非仰卧位时2:1）随机分组（1:1）。主要终点是3个月时的AHI，位置vs假手术。二次分析：治疗效果与年龄的相互作用；QoL包括Epworth嗜睡量表（ESS）和匹兹堡睡眠质量指数（PSQI）。在2019年10月至2022年8月期间，随机纳入120例基线AHI中位数为12.8事件/小时（IQR 9.2-18.5）的患者；体位疗法59例，假疗法61例；92例（77%）完成试验。与假手术相比，体位治疗显著降低了AHI - 4.41事件/小时（95% CI - 7.77至-1.06;p=0.011），改善了34%。体位治疗与假手术（基线ESS 8.8）相比，PSQI有显著改善：- 1.0 (95% CI - 2.1至0.0,p=0.04)，但ESS无显著改善：- 0.6 （95% CI - 1.8至0.6,p=0.3）。在年龄较小（18-64岁）和年龄较大（≥65岁）的人群中也有类似的结果。患者的床伴报告说，患者和他们自己的打鼾和睡眠质量都有所改善。超过一半使用主动设备的参与者选择继续使用。结论颈套体位疗法可减轻OSA的严重程度，改善睡眠质量，但在3个月内未改善嗜睡。据报道，床伴打鼾和睡眠质量有所改善。试验注册号[NCT04153240][1]。如有合理要求，可提供资料。在伦理委员会批准的范围内，可根据合理要求提供匿名数据。[1]: /查找/ external-ref ? link_type = CLINTRIALGOV&access_num = NCT04153240&atom = % 2 fthoraxjnl % 2恐惧% 2 f2025 % 2 f09 % 2 f24 % 2 fthorax - 2024 - 222681. -原子

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Vibrotactile positional therapy for the treatment of positional obstructive sleep apnoea: a multicentre, randomised controlled trial

Background New generation positional therapy devices provide vibrotactile feedback to patients with positional obstructive sleep apnoea (POSA), reducing supine sleep time and sleep apnoea severity. Longer-term effects on POSA severity, sleepiness and quality of life (QoL) are unclear. Methods A randomised, parallel, double-blinded trial compared neck-worn positional therapy with sham-positional therapy over 3 months (ClinicalTrials.gov: [NCT04153240][1]). Adult patients with POSA (apnoea/hypopnoea index (AHI) >5 events/hour, 2:1 when supine vs non-supine) were randomised (1:1). The primary endpoint was AHI at 3 months, positional versus sham. Secondary analyses: interaction between the treatment effect and age; QoL, including Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). Results Between October 2019 and August 2022, 120 patients with median baseline AHI of 12.8 events/hour (IQR 9.2–18.5) were randomised; 59 to positional therapy and 61 to sham; 92 (77%) completed the trial. Positional therapy significantly reduced the AHI by −4.41 events/hour (95% CI −7.77 to –1.06; p=0.011) compared with sham, a 34% improvement. There was a significant improvement in PSQI: −1.0 (95% CI −2.1 to 0.0; p=0.04), but not ESS: −0.6 (95% CI −1.8 to 0.6; p=0.3), with positional therapy compared with sham (baseline ESS 8.8). Similar results were seen in younger (18–64) and older (≥65) age groups. Patients’ bed partners reported improvements in snoring and sleep quality for the patient and themselves. Over half of participants using the active device opted to continue. Conclusion Neck-worn positional therapy reduced the severity of OSA and improved sleep quality but not sleepiness, over 3 months. Bed partner’s reported improvements in snoring and sleep quality. Trial registration number [NCT04153240][1]. Data are available upon reasonable request. Anonymised data may be provided upon reasonable request within the scope of the ethical committee approval. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04153240&atom=%2Fthoraxjnl%2Fearly%2F2025%2F09%2F24%2Fthorax-2024-222681.atom

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来源期刊

Thorax 医学-呼吸系统

CiteScore

16.10

自引率

2.00%

发文量

197

审稿时长

1 months

期刊介绍： Thorax stands as one of the premier respiratory medicine journals globally, featuring clinical and experimental research articles spanning respiratory medicine, pediatrics, immunology, pharmacology, pathology, and surgery. The journal's mission is to publish noteworthy advancements in scientific understanding that are poised to influence clinical practice significantly. This encompasses articles delving into basic and translational mechanisms applicable to clinical material, covering areas such as cell and molecular biology, genetics, epidemiology, and immunology.