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针对哮喘儿童及其父母的睡眠干预(SKIP研究):一项基于网络的新型共享管理试点研究。

Sleep intervention for children with asthma and their parents (SKIP Study): a novel web-based shared management pilot study.

作者信息

Sonney Jennifer T, Thompson Hilaire J, Landis Carol A, Pike Kenneth C, Chen Maida L, Garrison Michelle M, Ward Teresa M

机构信息

Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington.

Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington.

出版信息

J Clin Sleep Med. 2020 Jun 15;16(6):925-936. doi: 10.5664/jcsm.8374.

Abstract

STUDY OBJECTIVES

The objective of this study was to describe the feasibility, acceptability, and preliminary efficacy of a novel Sleep Intervention for Kids and Parents (SKIP). Parent and child primary sleep outcomes were total sleep time, wake after sleep onset (WASO), sleep efficiency (SE), and bedtime range.

METHODS

Children 6-11 years of age with asthma and 1 parent, both with behavioral sleep disturbance, enrolled in this single-group pilot. The 8-week shared management intervention included weekly online educational modules, goal setting, and progress reporting. Feasibility was measured by the number of dyads who were eligible, enrolled, and retained. Acceptability was measured by survey and semistructured interview. Total sleep time, WASO, SE, and bedtime range were measured by actigraphy at baseline, after the intervention, and 12-week follow-up. Mixed-effects regression models were used to determine change in sleep outcomes from baseline.

RESULTS

Thirty-three of 39 eligible dyads enrolled; of 29 dyads that started the intervention, 25 (86%) completed all study visits. SKIP was acceptable for 61% of children and 92% of parents. Compared with baseline, at follow-up, children had significantly improved WASO (-37 minutes; 95% confidence interval [CI], -44.5 to -29.7; P < .001), SE (5.4%; 95% CI, 4.2-6.5; P < .001), and bedtime range (-35.2 minutes; 95% CI, -42.9 to -27.5; P < .001). Parents also had significantly improved WASO (-13.9 minutes; 95% CI, -19.5 to -8.2; P < .001), SE (2.7%; 95% CI, 1.7-.7; P < .001), and bedtime range (-35.3 minutes; 95% CI, -51.0 to -19.7; P < .001).

CONCLUSIONS

SKIP was feasible, acceptable, and we observed improved child and parent sleep outcomes except total sleep time. Following refinements, further testing of SKIP in a controlled clinical trial is warranted. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Sleep Intervention for Kids and Parents: A Self-Management Pilot Study; URL: https://www.clinicaltrials.gov/ct2/show/study/NCT03144531; Identifier: NCT03144531.

摘要

研究目的

本研究的目的是描述一种新颖的儿童与家长睡眠干预方案(SKIP)的可行性、可接受性和初步疗效。家长和儿童的主要睡眠指标包括总睡眠时间、睡眠开始后觉醒时间(WASO)、睡眠效率(SE)和就寝时间范围。

方法

招募6至11岁患有哮喘且伴有行为性睡眠障碍的儿童及其1名家长参与这项单组试点研究。为期8周的共同管理干预包括每周的在线教育模块、目标设定和进展报告。通过符合条件、登记入组并完成研究的二元组数量来衡量可行性。通过调查和半结构化访谈来衡量可接受性。在基线、干预后和12周随访时通过活动记录仪测量总睡眠时间、WASO、SE和就寝时间范围。使用混合效应回归模型来确定睡眠指标相对于基线的变化。

结果

39个符合条件的二元组中有33个登记入组;在开始干预的29个二元组中,25个(86%)完成了所有研究访视。61%的儿童和92%的家长认为SKIP是可接受的。与基线相比,随访时儿童的WASO显著改善(-37分钟;95%置信区间[CI],-44.5至-29.7;P<.001)、SE(5.4%;95%CI,4.2 - 6.5;P<.001)和就寝时间范围(-35.2分钟;95%CI,-42.9至-27.5;P<.001)。家长的WASO(-13.9分钟;95%CI,-19.5至-8.2;P<.001)、SE(2.7%;95%CI,1.7 - 3.7;P<.001)和就寝时间范围(-35.3分钟;95%CI,-51.0至-19.7;P<.001)也有显著改善。

结论

SKIP是可行且可接受的,除总睡眠时间外,我们观察到儿童和家长的睡眠指标有所改善。经过改进后,有必要在对照临床试验中对SKIP进行进一步测试。临床试验注册:注册机构:ClinicalTrials.gov;名称:儿童与家长睡眠干预:一项自我管理试点研究;网址:https://www.clinicaltrials.gov/ct2/show/study/NCT03144531;标识符:NCT03144531 。 (注:原文中“SE (2.7%; 95% CI, 1.7-.7; P <.001)”这里推测可能有误,已按合理推测翻译为“SE(2.7%;95%CI,1.7 - 3.7;P<.001) ”)

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