title: Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children.
abstract: OBJECTIVE
  To determine the effects of bilevel positive airway pressure with pressure release technology (Bi-Flex) on adherence and efficacy in children and adolescents compared to standard continuous positive airway pressure (CPAP) therapy. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.
  
  
  METHODS
  This was a randomized, double-blinded clinical trial. Patients with obstructive sleep apnea were randomized to CPAP or Bi-Flex. Repeat polysomnography was performed on pressure at 3 months. Objective adherence data were obtained at 1 and 3 months.
  
  
  RESULTS
  56 children and adolescents were evaluated. There were no significant differences in the number of nights the device was turned on, or the mean number of minutes used at pressure per night for CPAP vs Bi-Flex (24 ± 6 vs 22 ± 9 nights, and 201 ± 135 vs 185 ± 165 min, respectively, for Month 1). The apnea hypopnea index decreased significantly from 22 ± 21/h to 2 ± 3/h on CPAP (p = 0.005), and 18 ± 15/h to 2 ± 2/h on Bi-Flex (p < 0.0005), but there was no significant difference between groups (p = 0.82 for CPAP vs Bi-Flex). The Epworth Sleepiness Scale decreased from 8 ± 5 to 6 ± 3 on CPAP (p = 0.14), and 10 ± 6 to 5 ± 5 on Bi-Flex (p < 0.0005; p = 0.12 for CPAP vs Bi-Flex).
  
  
  CONCLUSIONS
  Both CPAP and Bi-Flex are efficacious in treating children and adolescents with OSAS. However, adherence is suboptimal with both methods. Further research is required to determine ways to improve adherence in the pediatric population.
authors.affiliation: Sleep Center, Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. marcus@email.chop.edu
authors.forename: Carole L
authors.initials: CL
authors.lastname: Marcus
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Beck
authors.forename: Joel
authors.initials: J
authors.lastname: Traylor
authors.forename: Mary Anne
authors.initials: MA
authors.lastname: Cornaglia
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Meltzer
authors.forename: Natalie
authors.initials: N
authors.lastname: DiFeo
authors.forename: Laurie R
authors.initials: LR
authors.lastname: Karamessinis
authors.forename: John
authors.initials: J
authors.lastname: Samuel
authors.forename: Jennifer
authors.initials: J
authors.lastname: Falvo
authors.forename: Michelle
authors.initials: M
authors.lastname: DiMaria
authors.forename: Paul R
authors.initials: PR
authors.lastname: Gallagher
authors.forename: Heidi
authors.initials: H
authors.lastname: Beris
authors.forename: Mary Kate
authors.initials: MK
authors.lastname: Menello
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D045422:Continuous Positive Airway Pressure; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009765:Obesity / Q000150:complications; D010349:Patient Compliance; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000150:complications / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome