数字患者激励与支持工具对持续气道正压通气/自动调压智能持续气道正压通气依从性及日间嗜睡的影响：一项随机对照试验
Effect of a digital patient motivation and support tool on CPAP/APAP adherence and daytime sleepiness: a randomized controlled trial.
作者信息
Franke Christian, Piezonna Franziska, Schäfer Regina, Grimm Alexander, Loris Lisa-Marie, Schwaibold Matthias
机构信息
Medizinisches Versorgungszentrum GbR Sonneberg, 96515 Sonneberg, Germany.
Loewenstein Medical Technology GmbH+Co. KG, 76135 Karlsruhe, Germany.
出版信息
Sleep Biol Rhythms. 2023 Aug 17;22(1):49-63. doi: 10.1007/s41105-023-00479-9. eCollection 2024 Jan.
UNLABELLED
The purpose of this study was to assess the effect of a digital patient support (DPS) tool, complementary to standard care on continuous or automatic positive airway pressure (auto)CPAP adherence and daytime sleepiness after 12 weeks in patients diagnosed with severe obstructive sleep apnea (OSA). All patients with apnea-hypopnea index (AHI) ≥ 30 per hour were prospectively included and randomized to receive standard care (SC) or standard care with personalized DPS via a mobile app prototype version (SC + DPS). Patients in the SC + DPS arm received additionally automated feedback on their therapy, motivational messages and therapy recommendations. 100 patients completed the study (SC: 50, SC + DPS: 50). No differences were found in characteristics of SC vs. SC + DPS (mean ± SD) for age (53.9 ± 10.8 vs. 51.7 ± 12.3 years), initial diagnostic apnea-hypopnea index (51.1 ± 15.5 vs. 50.9 ± 17.7 events/h), BMI (33.8 ± 6.7 vs. 33.5 ± 4.5 kg/m), and Epworth Sleepiness Scale (ESS) baseline score (9.5 ± 4.2 vs. 9.1 ± 5.2). After 12 weeks, mean ESS score was significantly lower (SC: 7.6 ± 4.1 vs. SC + DPS: 5.5 ± 3.9; = 0.006) in the SC + DPS group vs. standard care group. Therapy adherence was significantly higher (SC: 268.7 ± 122.1 vs. SC + DPS: 338.8 ± 106.8 min; = 0.002) in the SC + DPS group compared to standard care group. No difference was found in the residual AHI between both groups. However, SC + DPS group showed a trend towards fewer phases with increased leakage compared to SC group. Intention-to-treat analysis (112 (56/56) patients) showed similar results. After 12 weeks, (auto)CPAP adherence and daytime sleepiness improved significantly in patients with severe OSA using the digital patient support tool. Registry: NCT05440279; Title: Effects of Telemedical Support on Therapeutic Results of CPAP Patients; URL: https://clinicaltrials.gov/ct2/show/NCT05440279; Date of registration: June 30, 2022.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s41105-023-00479-9.
未标注
本研究的目的是评估一种数字患者支持（DPS）工具对确诊为重度阻塞性睡眠呼吸暂停（OSA）患者在12周后持续或自动气道正压通气（auto）CPAP依从性和日间嗜睡的影响，该工具作为标准治疗的补充。所有呼吸暂停低通气指数（AHI）≥30次/小时的患者被前瞻性纳入并随机分为接受标准治疗（SC）或通过移动应用原型版本接受个性化DPS的标准治疗（SC + DPS）。SC + DPS组的患者还额外获得了关于其治疗的自动反馈、激励信息和治疗建议。100名患者完成了研究（SC组：50名，SC + DPS组：50名）。SC组与SC + DPS组在年龄（53.9±10.8岁 vs. 51.7±12.3岁）、初始诊断呼吸暂停低通气指数（51.1±15.5次/小时 vs. 50.9±17.7次/小时）、体重指数（33.8±6.7 vs. 33.5±4.5kg/m²）和爱泼沃斯嗜睡量表（ESS）基线评分（9.5±4.2 vs. 9.1±5.2）方面未发现差异。12周后，SC + DPS组的平均ESS评分显著低于标准治疗组（SC组：7.6±4.1 vs. SC + DPS组：5.5±3.9；P = 0.006）。SC + DPS组的治疗依从性显著高于标准治疗组（SC组：268.7±122.1分钟 vs. SC + DPS组：338.8±106.8分钟；P = 0.002）。两组之间的残余AHI未发现差异。然而，与SC组相比，SC + DPS组显示漏气增加阶段较少的趋势。意向性分析（112例（56/56）患者）显示了相似的结果。在12周后，使用数字患者支持工具的重度OSA患者的（auto）CPAP依从性和日间嗜睡情况显著改善。注册信息：NCT05440279；标题：远程医疗支持对CPAP患者治疗结果的影响；网址：https://clinicaltrials.gov/ct2/show/NCT05440279；注册日期：2022年6月30日。
补充信息
在线版本包含可在10.1007/s41105-023-00479-9获取的补充材料。
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