Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Feb 15;8(1):37-42.
doi: 10.5664/jcsm.1656.

Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children

Carole L Marcus  1 , Suzanne E Beck, Joel Traylor, Mary Anne Cornaglia, Lisa J Meltzer, Natalie DiFeo, Laurie R Karamessinis, John Samuel, Jennifer Falvo, Michelle DiMaria, Paul R Gallagher, Heidi Beris, Mary Kate Menello
Affiliations
Randomized Controlled Trial

Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children

Carole L Marcus et al. J Clin Sleep Med. .

Abstract

Study objectives: 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.

Keywords: Bi-Flex; CPAP; obstructive sleep apnea.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow diagram of subject enrollment
Figure 2
Figure 2
The percentage of obese and non-obese subjects with varying medical conditions are shown
See this image and copyright information in PMC

Comment in

References

    1. American Academy of Pediatrics. Clinical practice guideline: diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2002;109:704–12. - PubMed
    1. Marcus CL, Rosen G, Ward SL, et al. Adherence to and effectiveness of positive airway pressure therapy in children with obstructive sleep apnea. Pediatrics. 2006;117:e442–51. - PubMed
    1. O'Donnell AR, Bjornson CL, Bohn SG, Kirk VG. Compliance rates in children using noninvasive continuous positive airway pressure. Sleep. 2006;29:651–8. - PubMed
    1. Uong EC, Epperson M, Bathon SA, Jeffe DB. Adherence to nasal positive airway pressure therapy among school-aged children and adolescents with obstructive sleep apnea syndrome. Pediatrics. 2007;120:e1203–11. - PubMed
    1. Reeves-Hoche MK, Hudgel DW, Meck R, Witteman R, Ross A, Zwillich CW. Continuous versus bilevel positive airway pressure for obstructive sleep apnea. Am J Respir Crit Care Med. 1995;151:443–9. - PubMed

Publication types