Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial

Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial
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DOI:
10.1016/s0140-6736(98)10532-9
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发表时间:
1999-06-19
期刊:
影响因子:
168.9
通讯作者:
Stradling, JR
Stradling, JR
中科院分区:
医学1区
文献类型:
--
作者:
Jenkinson, C;Davies, RJO;Stradling, JR

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背景 经鼻持续气道正压通气 (NCPAP) 被广泛用于治疗阻塞性睡眠呼吸暂停。然而,迄今为止,还没有针对该疗法与匹配良好的对照进行的随机对照试验。我们进行了一项针对阻塞性睡眠呼吸暂停的治疗性 NCPAP 的随机前瞻性平行试验,与接受亚治疗性 NCPAP 的对照组进行比较。方法 患有阻塞性睡眠呼吸暂停的男性(定义为在夜间睡眠研究中由阻塞性睡眠呼吸暂停引起的 Epworth 嗜睡评分为 10 或以上且每小时 10 次或以上下降超过 4% SaO(2))被随机分配为治疗性 NCPAP 或亚治疗性 NCPAP(约 1 cm) H2O)1个月。主要结果是主观嗜睡(Epworth 嗜睡评分)、客观嗜睡(维持清醒测试)以及自我报告的功能和幸福感的 SF-36 问卷测量。 结果 107 名男性参与了研究:53 名接受亚治疗性 NCPAP,54 名接受治疗性 NCPAP。两个治疗组使用 NCPAP 的时间相似:每晚 54 小时(治疗)和 4.6 小时(亚治疗)。与基线相比,亚治疗 NCPAP 不会改变每小时过夜 SaO(2) 下降次数,因此可作为对照。在所有主要结局指标中,治疗性 NCPAP 均优于亚治疗性 NCPAP。治疗性 NCPAP 的 Epworth 评分从中位数 15.5 降至 7.0,亚治疗 NCPAP 的 Epworth 评分从中位数 15.0 降至 13.0(治疗之间,p
Background Nasal continuous positive airway pressure (NCPAP) is widely used as a treatment for obstructive sleep apnoea. However, to date there are no randomised controlled trials of this therapy against a well-matched control. We undertook a randomised prospective parallel trial of therapeutic NCPAP for obstructive sleep apnoea compared with a control group on subtherapeutic NCPAP.Methods Men with obstructive sleep apnoea, defined as an Epworth sleepiness score of 10 or more and ten or more dips per h of more than 4% SaO(2) caused by obstructive sleep apnoea on overnight sleep study, were randomly assigned therapeutic NCPAP or subtherapeutic NCPAP (about 1 cm H2O) for 1 month. Primary outcomes were subjective sleepiness (Epworth sleepiness score), objective sleepiness (maintenance of wakefulness test), and SF-36 questionnaire measurements of self-reported functioning and well-being.Findings 107 men entered the study: 53 received subtherapeutic NCPAP and 54 therapeutic NCPAP. Use of NCPAP by the two treatment groups was similar: 54 h (therapeutic) and 4.6 h (subtherapeutic) per night. Subtherapeutic NCPAP did not alter the overnight number of SaO(2) dips per h compared with baseline, and thus acted as a control. Therapeutic NCPAP was superior to subtherapeutic NCPAP in all primary outcome measures. The Epworth score was decreased from a median of 15.5 to 7.0 on therapeutic NCPAP, and from 15.0 to 13.0 on subtherapeutic NCPAP (between treatments, p