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

Longer-term effects on POSA severity, sleepiness and quality of life (QoL) are unclear.

POSA的严重程度、嗜睡程度和生活质量（QoL）的长期效果尚不明确。

Methods

A randomised, parallel, double-blinded trial compared neck-worn positional therapy with sham-positional therapy over 3 months (ClinicalTrials.gov: NCT04153240).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.

一项随机、平行、双盲试验比较了颈部佩戴的位置疗法与安慰剂位置疗法的效果，试验持续3个月（ClinicalTrials.gov: NCT04153240）。成年患者中，符合POSA诊断标准（呼吸暂停/低通气指数（AHI）>5次/小时，仰卧位与非仰卧位之比为2:1）的患者被随机分配（1:1）。主要终点是3个月时的AHI，比较位置疗法与安慰剂疗法的效果。

Secondary analyses: interaction between the treatment effect and age; QoL, including Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI).

次要分析包括：治疗效果与年龄之间的相互作用；生活质量评估，包括Epworth嗜睡量表（ESS）和匹兹堡睡眠质量指数（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.

在2019年10月至2022年8月期间，120名患者随机分配接受治疗，基线AHI中位数为每小时12.8次事件（四分位数间距9.2-18.5）；59名接受体位治疗，61名接受安慰剂治疗；92名（77%）完成了试验。与安慰剂相比，体位治疗显著降低了AHI -4.41次/小时（95%置信区间-7.77至-1.06；p=0.011），改善了34%。

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).

与安慰剂相比，体位治疗在PSQI上显著改善：-1.0（95%置信区间-2.1至0.0；p=0.04），但在ESS上没有显著改善：-0.6（95%置信区间-1.8至0.6；p=0.3），基线ESS为8.8。

Similar results were seen in younger (18-64) and older (≥65) age groups.

在年轻（18-64岁）和老年（≥65岁）组中看到了类似的结果。

Patients' bed partners reported improvements in snoring and sleep quality for the patient and themselves.

患者的床伴报告称，患者及其自身的打鼾和睡眠质量有所改善。

Over half of participants using the active device opted to continue.

超过一半使用该活跃装置的参与者选择继续使用。

Conclusions

Neck-worn positional therapy reduced the severity of OSA and improved sleep quality but not sleepiness, over 3 months.

颈戴式体位治疗在3个月内减轻了阻塞性睡眠呼吸暂停（OSA）的严重程度并改善了睡眠质量，但没有改善嗜睡症状。

Bed partner's reported improvements in snoring and sleep quality.

床伴报告的打鼾和睡眠质量的改善。

trial_registration_number

NCT04153240.

NCT04153240。