临床医生引导的数字CBT-I改善共病失眠与OSA患者的睡眠质量和呼吸暂停严重程度：一项双盲随机临床试验
Clinician-guided digital CBT-I improves sleep quality and apnea severity in patients with co-morbid insomnia and OSA: A Double-Blind, Randomized Clinical Trial.
文献信息
| PMID | 42958645 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Yuan Shi |
| 作者单位 | Sleep Medicine Center, Mental Health Center, National Center for Mental Disorders, Sleep Research Laboratory, West China Hospital, Sichuan University, Chengdu, China. |
| 期刊 | American journal of respiratory and critical care medicine |
| SCI 分区 | Q1 |
| IF | 21.2 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
背景： 失眠认知行为疗法（CBT-I）是失眠公认的一线治疗，但其在共病失眠与阻塞性睡眠呼吸暂停（COMISA）患者中的可扩展性和安全性仍不明确。临床医生引导的数字CBT-I（D-CBT-I）是一种潜在治疗选择，可能解决COMISA中的这些局限。
目的： 评估临床医生引导的D-CBT-I与睡眠卫生教育（SHE）相比在COMISA患者中的有效性。
方法： 本随机试验（n=88）比较临床医生引导的D-CBT-I（6次每周在线课程：睡眠限制、睡眠卫生、刺激控制、认知重构、复发预防）与单纯SHE。盲法结局评估在基线、治疗后（6周）和3个月随访时进行。主要结局为治疗后和3个月随访时的失眠严重指数（ISI）和匹兹堡睡眠质量指数（PSQI）评分。次要结局包括日间嗜睡、睡眠参数、OSA严重程度、神经认知功能和不良事件。
测量与主要结果： 在3个月随访时，意向性治疗分析显示，与SHE相比，D-CBT-I在ISI（-9.5 vs. -4.0分；d=-1.18，P=0.001）和PSQI（-4.9 vs. -1.8分；d=-0.87，P=0.001）方面改善显著更大；D-CBT-I还减少了主观嗜睡（Epworth嗜睡量表；-3.4 vs. -1.0分；d=-0.68，P<0.001）。在治疗后，D-CBT-I降低了呼吸暂停低通气指数（在实验室进行的有监督多导睡眠监测；-6.0 vs. +2.0次/小时；d=-0.64，P=0.019）。尽管在第2-4周出现ESS短暂升高，但未报告功能损害或嗜睡相关不良事件。在元认知和执行功能方面也观察到额外获益。
结论： 临床医生引导的D-CBT-I改善了COMISA患者的失眠和OSA严重程度，并增强了认知功能。
试验注册： 中国临床试验注册中心；编号：ChiCTR2500099854；URL：https://www.chictr.org.cn/showproj.html?proj=267457。
英文摘要
RATIONALE: Cognitive behavioral therapy for insomnia (CBT-I) is the accepted first-line treatment for insomnia, but its scalability and safety in patients with co-morbid insomnia and obstructive sleep apnea (COMISA) remain unclear. Clinician-guided digital CBT-I (D-CBT-I) is a potential treatment option that may address these limitations in COMISA.
OBJECTIVE: To evaluate the effectiveness of clinician-guided D-CBT-I versus sleep hygiene education (SHE) in patients with COMISA.
METHODS: This randomized trial (n = 88) compared clinician-guided D-CBT-I (6 weekly online sessions: sleep restriction, sleep hygiene, stimulus control, cognitive restructuring, relapse prevention) with SHE alone. Blinded outcome assessments were conducted at baseline, posttreatment (6 weeks), and 3-month follow-up. Primary outcomes were Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores at posttreatment and 3-month follow-up. Secondary outcomes included daytime sleepiness, sleep parameters, OSA severity, neurocognitive function, and adverse events.
MEASUREMENTS AND MAIN RESULTS: At 3-month follow-up, intention-to-treat analysis showed significantly greater improvements with D-CBT-I versus SHE on ISI (-9.5 vs. -4.0 points; d = -1.18, P = 0.001) and PSQI (-4.9 vs. -1.8 points; d = -0.87, P = 0.001); D-CBT-I also reduced subjective sleepiness (Epworth Sleepiness Scale; -3.4 vs. -1.0 points; d = -0.68, P < 0.001). At posttreatment, D-CBT-I reduced the apnea-hypopnea index (attended in-laboratory polysomnography; -6.0 vs. +2.0 events/h; d = -0.64, P = 0.019). Although transient increases in ESS occurred at weeks 2-4, no functional impairment or sleepiness-related adverse events were reported. Additional benefits were observed in metacognition and executive function.
CONCLUSION: Clinician-guided D-CBT-I improved insomnia and OSA severity, and enhanced cognitive function in COMISA patients.
TRIAL REGISTRATION: Chinese Clinical Trial Registry; NO.: ChiCTR2500099854; URL: https://www.chictr.org.cn/showproj.html?proj=267457.