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阻塞性睡眠呼吸暂停减重自我导向干预的实用性试验(POWER)

Pragmatic trial of a self-directed intervention for weight loss in obstructive sleep apnea (POWER).

临床研究耳科IF 21.2Q1

文献信息

中文摘要

背景: 自我导向的生活方式干预可能改善阻塞性睡眠呼吸暂停(OSA)患者获得减重照护的机会,但其在常规实践中的有效性尚不清楚。
目的: 检验主动提供的自我导向生活方式干预与常规照护相比,是否能改善体重和睡眠相关生活质量。
方法: POWER研究纳入OSA且体重指数为30-45 kg/m2的患者,从全国退伍军人事务(VA)中心招募,并将参与者随机分配至基于糖尿病预防计划的自我导向干预(包括视频课程、阅读材料和定期教练提醒)或常规照护。共同主要结局为从基线至随机化后12个月功能性睡眠结局问卷(FOSQ)的变化和临床体重(千克,kg)的变化。鉴于有两个主要结局,我们将显著性定义为p = 0.025。
测量与主要结果: 本试验随机分配了696名参与者。平均年龄为56.2岁(SD 12.2),19.7%自认为女性。12个月时临床体重数据在干预组可获得81.9%、对照组可获得83.6%。未校正体重在干预组下降2.1 kg(SD 6.8),对照组下降0.9 kg(SD 5.9)(校正组间差异:-1.1 kg,95%CI -2.0, -0.1;p = 0.037)。12个月时FOSQ数据在干预组可获得78.2%、对照组可获得90.5%。从基线至12个月,未校正FOSQ在干预组改善1.4分(SD 2.7),对照组改善0.9分(SD 2.9)(校正组间差异:0.6分,95%CI 0.2, 1.0;p = 0.001)。
结论与意义: 在OSA合并肥胖的参与者中,自我导向生活方式干预未改善减重,并导致睡眠相关生活质量的改善,但临床重要性有限。
试验注册: Clinicaltrials.gov NCT05104450,注册日期2021年10月19日。

英文摘要

RATIONALE: Self-directed lifestyle interventions may improve access to weight loss care in obstructive sleep apnea (OSA), but effectiveness in routine practice is unknown.
OBJECTIVE: Test whether a proactively delivered self-directed lifestyle intervention improves weight and sleep-related quality of life versus usual care.
METHODS: POWER enrolled patients with OSA and body mass index of 30-45 kg/m2, recruited from Veteran Affairs (VA) sites nationwide, and randomized participants to a self-directed intervention based on the Diabetes Prevention Program with video-based sessions, readings, and regular coaching reminders or usual care. Co-primary outcomes were change in Functional Outcomes of Sleep Questionnaire (FOSQ) and clinical weight in kilograms (kg) from baseline to 12 months post-randomization. Given two primary outcomes, we defined significance at p = 0.025.
MEASUREMENTS AND MAIN RESULTS: This trial randomized 696 participants. Mean age was 56.2 years (SD 12.2), with 19.7% identifying as female. Clinical weights at 12 months were available for 81.9% of intervention and 83.6% of control participants. Unadjusted weight declined 2.1 kg (SD 6.8) in intervention and 0.9 kg (SD 5.9) in control (adjusted between-group difference: -1.1 kg, 95%CI -2.0, -0.1; p = 0.037). FOSQ measures were available at 12 months for 78.2% of intervention and 90.5% of control participants. From baseline to 12 months, unadjusted FOSQ improved 1.4 (SD 2.7) points in intervention and 0.9 (SD 2.9) points in control (adjusted between-group difference: 0.6 points, 95%CI 0.2, 1.0; p = 0.001).
CONCLUSION AND RELEVANCE: Among participants with OSA and obesity, a self-directed lifestyle intervention did not improve weight loss and led to improvements in sleep-related quality of life that are of limited clinical importance.
TRIAL REGISTRATION: Clinicaltrials.gov NCT05104450, registered 10/19/2021.