title: Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  www.clinicaltrials.gov, identifier: NCT01768065.
authors.affiliation: 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.
authors.forename: Suraiya A
authors.initials: SA
authors.lastname: Kureshi
authors.affiliation: Clinical and Translational Research Center, Children's Hospital of Philadelphia, Philadelphia, PA.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Gallagher
authors.affiliation: Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: McDonough
authors.affiliation: Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
authors.forename: Mary Anne
authors.initials: MA
authors.lastname: Cornaglia
authors.affiliation: Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
authors.forename: Jill
authors.initials: J
authors.lastname: Maggs
authors.affiliation: Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
authors.forename: John
authors.initials: J
authors.lastname: Samuel
authors.affiliation: Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
authors.forename: Joel
authors.initials: J
authors.lastname: Traylor
authors.affiliation: Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
authors.forename: Carole L
authors.initials: CL
authors.lastname: Marcus
mesh_terms: D000293:Adolescent; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D010865:Pilot Projects; D017286:Polysomnography; D011175:Positive-Pressure Respiration / Q000295:instrumentation* / Q000379:methods; D020181:Sleep Apnea, Obstructive / Q000628:therapy*
keywords: nasal expiratory positive airway pressure; obstructive sleep apnea syndrome; pediatrics