Center for Sleep Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN 55905, USA.
J Clin Sleep Med. 2013 May 15;9(5):439-44. doi: 10.5664/jcsm.2660.
To determine whether pretreatment with zaleplon immediately before CPAP titration improves 1-month CPAP adherence in subjects newly diagnosed with OSA.
Prospective, randomized, double-blinded, placebo-controlled trial of a single dose of zaleplon 10 mg or matching placebo at the start of CPAP titration during laboratory-based, split-night polysomnography (PSG). Baseline sleep symptoms were assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS). CPAP usage and change in symptom questionnaire responses were assessed at 1-month follow-up.
One hundred thirty-four newly diagnosed OSA patients undergoing their initial split-night PSG (49.8 ± 11.3 years old with an apnea-hypopnea index of 16.5 (7, 32) [median (interquartile range)] were randomized to zaleplon (n = 73) or placebo (n = 63). Complete follow-up data were available in 83 subjects (44 zaleplon group; 39 placebo group). CPAP was used for 6.5 (5, 7) h/day with zaleplon versus 6.5 (5, 8) h/ day with placebo (p = 0.64). Improvements in FOSQ and ESS scores did not differ between the two groups.
A single dose of zaleplon at the start of a split-night CPAP titration does not result in superior CPAP adherence or improvement in symptoms at 1-month compared to placebo. Our data show that zaleplon is safe and is associated with shorter sleep latency during CPAP titration, but it does not translate into improved short-term CPAP adherence.
确定在 CPAP 滴定开始前即刻给予扎来普隆预处理是否能提高新诊断为 OSA 的患者 1 个月 CPAP 依从性。
前瞻性、随机、双盲、安慰剂对照试验,在基于实验室的、分夜多导睡眠图(PSG)中 CPAP 滴定开始时,受试者单次给予扎来普隆 10mg 或匹配安慰剂。使用睡眠功能结果问卷(FOSQ)和 Epworth 嗜睡量表(ESS)评估基线睡眠症状。在 1 个月随访时评估 CPAP 使用情况和症状问卷应答的变化。
134 例新诊断的 OSA 患者进行了首次分夜 PSG(49.8±11.3 岁,呼吸暂停低通气指数为 16.5(7,32)[中位数(四分位距)]),随机分为扎来普隆组(n=73)或安慰剂组(n=63)。83 例患者(扎来普隆组 44 例,安慰剂组 39 例)完成了完整的随访。扎来普隆组 CPAP 使用时间为 6.5(5,7)h/d,安慰剂组为 6.5(5,8)h/d(p=0.64)。两组的 FOSQ 和 ESS 评分改善无差异。
与安慰剂相比,在分夜 CPAP 滴定开始时给予单剂量扎来普隆并不能在 1 个月时提高 CPAP 依从性或改善症状。我们的数据表明,扎来普隆是安全的,并且与 CPAP 滴定期间的睡眠潜伏期缩短有关,但这并不能转化为短期 CPAP 依从性的改善。