唑吡坦对OSA患者CPAP适应的影响:一项交叉、随机、双盲、安慰剂对照试验。

IF 2.9 3区 医学 Q1 CLINICAL NEUROLOGY
Piyakorn Pisalnoradej, Wish Banhiran, Navarat Kasemsuk
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引用次数: 0

摘要

研究目的:比较唑吡坦与安慰剂对阻塞性睡眠呼吸暂停(OSA)患者持续气道正压(CPAP)适应的短期效果。方法:这项随机、双盲、安慰剂对照的交叉试验纳入了CPAP初始的OSA患者,这些患者需要接受CPAP治疗。参与者被随机分配接受唑吡坦10 mg或相同的安慰剂胶囊,在睡前30 分钟给药,持续1 周。在第二周,他们转到另一种治疗。24小时的洗脱期将两个治疗阶段分开。结果:28名参与者(平均年龄54.5 ± 13.7 岁;57.1%男性)完成了研究。唑吡坦和安慰剂每晚平均CPAP使用率无显著差异(平均差异0.18,95% CI -0.39至0.75)。使用CPAP的夜间百分比 ≥ 4 小时也无显著差异(平均差异2.60,95% CI -5.65 ~ 10.87)。治疗顺序对CPAP依从性无影响(P = 0.87)。按性别、疾病严重程度和觉醒指数进行的亚组分析显示,唑吡坦对依从性没有显著影响。无严重不良事件报告,最常见的轻微不良事件为头晕(7.14%)。结论:在适应期,短期使用唑吡坦并不能提高CPAP的依从性。这些发现强调了采用多种适应策略的重要性,而不是依赖常规使用唑吡坦。有必要进行更大规模的随访研究来证实这些结果。临床试验注册:注册:ClinicalTrials.gov;标识符:NCT06084130。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The effect of zolpidem on CPAP acclimatization in patients with OSA: a crossover, randomized, double-blinded, placebo-controlled trial.

Study objectives: To evaluate the short-term effect of zolpidem on continuous positive airway pressure (CPAP) acclimatization in patients with obstructive sleep apnea (OSA) compared with placebo.

Methods: This randomized, double-blind, placebo-controlled crossover trial enrolled CPAP-naive OSA patients who were indicated for CPAP therapy. Participants were randomly assigned to receive either zolpidem 10 mg or an identical placebo capsule, administered 30 minutes before bedtime for 1 week. In the second week, they crossed over to the alternate treatment. A 24-hour washout period separated the two treatment phases.

Results: Twenty-eight participants (mean age 54.5 ± 13.7 years; 57.1% male) completed the study. The mean CPAP usage per night did not differ significantly between zolpidem and placebo (mean difference 0.18, 95% CI -0.39 to 0.75). The percentage of nights with CPAP use ≥ 4 hours also showed no significant difference (mean difference 2.60, 95% CI -5.65 to 10.87). Treatment sequence did not affect CPAP adherence (P = 0.87). Subgroup analyses by sex, disease severity, and arousal index revealed no significant impact of zolpidem on adherence. No serious adverse events were reported, and the most common minor adverse event was dizziness (7.14%).

Conclusions: Short-term zolpidem use did not improve CPAP adherence during the acclimatization period. These findings underscore the importance of employing multiple acclimatization strategies rather than relying on routine zolpidem use. Larger-scale studies with extended follow-up are warranted to confirm these results.

Clinical trial registration: Registry: ClinicalTrials.gov; Identifier: NCT06084130.

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来源期刊
CiteScore
6.20
自引率
7.00%
发文量
321
审稿时长
1 months
期刊介绍: Journal of Clinical Sleep Medicine focuses on clinical sleep medicine. Its emphasis is publication of papers with direct applicability and/or relevance to the clinical practice of sleep medicine. This includes clinical trials, clinical reviews, clinical commentary and debate, medical economic/practice perspectives, case series and novel/interesting case reports. In addition, the journal will publish proceedings from conferences, workshops and symposia sponsored by the American Academy of Sleep Medicine or other organizations related to improving the practice of sleep medicine.
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