Suraiya A Kureshi1, Paul R Gallagher2, Joseph M McDonough3, Mary Anne Cornaglia3, Jill Maggs3, John Samuel3, Joel Traylor3, Carole L Marcus3. 1. 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. 2. Clinical and Translational Research Center, Children's Hospital of Philadelphia, Philadelphia, PA. 3. Sleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
Abstract
STUDY OBJECTIVES: 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. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, identifier: NCT01768065.
RCT Entities:
STUDY OBJECTIVES: 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. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, identifier: NCT01768065.
Authors: Michael G Stewart; David L Witsell; Timothy L Smith; Edward M Weaver; Bevan Yueh; Maureen T Hannley Journal: Otolaryngol Head Neck Surg Date: 2004-02 Impact factor: 3.497
Authors: Carole L Marcus; Reneé H Moore; Carol L Rosen; Bruno Giordani; Susan L Garetz; H Gerry Taylor; Ron B Mitchell; Raouf Amin; Eliot S Katz; Raanan Arens; Shalini Paruthi; Hiren Muzumdar; David Gozal; Nina Hattiangadi Thomas; Janice Ware; Dean Beebe; Karen Snyder; Lisa Elden; Robert C Sprecher; Paul Willging; Dwight Jones; John P Bent; Timothy Hoban; Ronald D Chervin; Susan S Ellenberg; Susan Redline Journal: N Engl J Med Date: 2013-05-21 Impact factor: 91.245