Megan E Petrov, Dana R Epstein, Lois Krahn, Michael Todd, John G Park, Erik K St Louis, Timothy I Morgenthaler, Coles M Hoffmann, Kristina Hasanaj, Kevin Hollingshead, Tsung-Yen Yu, Matthew P Buman
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Patients were recruited from two sleep medicine centers and followed over the first 60 days of PAP. Feasibility and acceptability were measured by recruitment/retention rates, app usage, differences in post-trial Treatment Evaluation Questionnaire (TEQ) scores, and patient interviews. Exploratory, intent-to-treat logistic and linear mixed models estimated PAP adherence and clinical outcomes.</p><p><strong>Results: </strong>Of 103 eligible participants, 87 were enrolled (<i>SleepWell24 n</i> = 40, control <i>n</i> = 47; mean 57.6y [SD = 12.3], 44.8% female). Retention was ≥95% across arms. There were no significant differences in TEQ scores. <i>SleepWell24</i> participants engaged with the app on 62.9% of trial days. PAP use was high across both arms (<i>SleepWell24</i> vs. Control: mean hours 5.98 vs. 5.86). 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引用次数: 0
摘要
目的:探讨SleepWell24(一款多组件、循证智能手机应用程序)在初次接受PAP治疗的阻塞性睡眠呼吸暂停(OSA)患者中提高气道正压治疗(PAP)依从性的可行性和可接受性。方法:在一项单盲随机对照试验中，将附有活动监测器的SleepWell24与常规护理加活动监测器及其相关应用程序进行比较。SleepWell24提供关于PAP使用和睡眠/身体活动模式以及慢性疾病管理的客观反馈。患者从两个睡眠医学中心招募，并在PAP的前60天进行随访。可行性和可接受性通过招募/保留率、应用程序使用率、试验后治疗评估问卷(TEQ)评分差异和患者访谈来衡量。探索性、治疗意向logistic和线性混合模型估计PAP依从性和临床结果。结果:在103名符合条件的参与者中，87人入组(SleepWell24 n = 40, control n = 47;平均57.6y [SD = 12.3]，女性44.8%)。两臂间保留率≥95%。TEQ得分无显著差异。SleepWell24的参与者在62.9%的试验天数中使用了这款应用。两组PAP使用率均较高(SleepWell24 vs. Control:平均小时数5.98 vs. 5.86)。PAP依从性和临床结果没有差异。结论:SleepWell24在pap初始OSA患者中是可行且可接受的。临床试验注册:NCT03156283https://www.clinicaltrials.gov/study/NCT03156283。
SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial.
Objective: To investigate the feasibility and acceptability of SleepWell24, a multicomponent, evidence-based smartphone application, to improve positive airway pressure therapy (PAP) adherence, among patients with obstructive sleep apnea (OSA) naive to PAP.
Methods: In a single-blind randomized controlled trial, SleepWell24, with a companion activity monitor was compared to usual care plus the activity monitor and its associated app. SleepWell24 provides objective feedback on PAP usage and sleep/physical activity patterns, and chronic disease management. Patients were recruited from two sleep medicine centers and followed over the first 60 days of PAP. Feasibility and acceptability were measured by recruitment/retention rates, app usage, differences in post-trial Treatment Evaluation Questionnaire (TEQ) scores, and patient interviews. Exploratory, intent-to-treat logistic and linear mixed models estimated PAP adherence and clinical outcomes.
Results: Of 103 eligible participants, 87 were enrolled (SleepWell24 n = 40, control n = 47; mean 57.6y [SD = 12.3], 44.8% female). Retention was ≥95% across arms. There were no significant differences in TEQ scores. SleepWell24 participants engaged with the app on 62.9% of trial days. PAP use was high across both arms (SleepWell24 vs. Control: mean hours 5.98 vs. 5.86). There were no differences in PAP adherence or clinical outcomes.
Conclusions: SleepWell24 was feasible and acceptable among PAP-naive patients with OSA.
期刊介绍：
Behavioral Sleep Medicine addresses behavioral dimensions of normal and abnormal sleep mechanisms and the prevention, assessment, and treatment of sleep disorders and associated behavioral and emotional problems. Standards for interventions acceptable to this journal are guided by established principles of behavior change. Intending to serve as the intellectual home for the application of behavioral/cognitive science to the study of normal and disordered sleep, the journal paints a broad stroke across the behavioral sleep medicine landscape. Its content includes scholarly investigation of such areas as normal sleep experience, insomnia, the relation of daytime functioning to sleep, parasomnias, circadian rhythm disorders, treatment adherence, pediatrics, and geriatrics. Multidisciplinary approaches are particularly welcome. The journal’ domain encompasses human basic, applied, and clinical outcome research. Behavioral Sleep Medicine also embraces methodological diversity, spanning innovative case studies, quasi-experimentation, randomized trials, epidemiology, and critical reviews.
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