Kureshi Suraiya A, Gallagher Paul R, McDonough Joseph M, Cornaglia Mary Anne, Maggs Jill, Samuel John, Traylor Joel, Marcus Carole L
Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA ; Divisions of Pulmonary and Sleep Medicine, Children's National Medical Center, Washington, DC.
Clinical and Translational Research Center, Children's Hospital of Philadelphia, Philadelphia, PA.
J Clin Sleep Med. 2014 Jun 15;10(6):663-9. doi: 10.5664/jcsm.3796.
Alternative therapies for childhood obstructive sleep apnea syndrome (OSAS) are needed as OSAS may persist despite adenotonsillectomy, and continuous positive airway pressure (CPAP) adherence is low. Nasal expiratory positive airway pressure (NEPAP) devices have not been studied in children. We hypothesized that NEPAP would result in polysomnographic improvement. Further, we aimed to determine NEPAP adherence, effects on sleepiness, behavior, and quality of life.
A randomized, double-blind, placebo-controlled, crossover pilot study was performed. CPAP candidates, 8-16 years old, underwent NEPAP and placebo polysomnograms. Subjects with ≥ 50% reduction in the apnea hypopnea index (AHI) from placebo to NEPAP night or AHI < 5/h on NEPAP night wore NEPAP at home for 30 days. Adherence was assessed by daily phone calls/emails and collecting used devices.
Fourteen subjects (age 13.4 ± 1.9 years, BMI z-scores 2.2 ± 1 [mean ± SD]) were studied. There was significant improvement in the obstructive apnea index with NEPAP vs. placebo: 0.6 (0-21.1)/h vs. 4.2 (0-41.9)/h (median [range], p = 0.010) and trends for improvement in other polysomnographic parameters. However, responses were variable, with 3 subjects not improving and 2 worsening. Older children and those with less hypercapnia had a better response. Eight subjects were sent home with devices; one was lost to follow-up, and adherence in the remainder was 83% of nights; these subjects had a significant improvement in sleepiness and quality of life.
NEPAP devices are a potential alternative therapy for OSAS in a small subset of children. Due to variability in individual responses, efficacy of NEPAP should be evaluated with polysomnography.
www.clinicaltrials.gov, identifier: NCT01768065.
儿童阻塞性睡眠呼吸暂停综合征（OSAS）需要替代疗法，因为即便进行了腺样体扁桃体切除术，OSAS仍可能持续存在，而且持续气道正压通气（CPAP）的依从性较低。鼻呼气末正压通气（NEPAP）设备尚未在儿童中进行研究。我们假设NEPAP会使多导睡眠图得到改善。此外，我们旨在确定NEPAP的依从性、对嗜睡、行为和生活质量的影响。
进行了一项随机、双盲、安慰剂对照、交叉试点研究。年龄在8至16岁的CPAP适用儿童接受了NEPAP和安慰剂多导睡眠图检查。从安慰剂夜到NEPAP夜呼吸暂停低通气指数（AHI）降低≥50%或NEPAP夜AHI<5次/小时的受试者在家中佩戴NEPAP 30天。通过每日电话/电子邮件和收集使用过的设备来评估依从性。
研究了14名受试者（年龄13.4±1.9岁，体重指数z评分2.2±1[均值±标准差]）。与安慰剂相比，NEPAP使阻塞性呼吸暂停指数有显著改善：0.6（0 - 21.1）次/小时对4.2（0 - 41.9）次/小时（中位数[范围]，p = 0.010），其他多导睡眠图参数也有改善趋势。然而，反应存在差异，3名受试者没有改善，2名受试者病情恶化。年龄较大的儿童和高碳酸血症较轻的儿童反应较好。8名受试者被送回家中使用设备；1名失访，其余受试者的依从性为83%的夜晚；这些受试者的嗜睡和生活质量有显著改善。
NEPAP设备是一小部分儿童OSAS的潜在替代疗法。由于个体反应存在差异，NEPAP的疗效应通过多导睡眠图进行评估。
