Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome

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.

Keywords: nasal expiratory positive airway pressure; obstructive sleep apnea syndrome; pediatrics.

Figures

Figure 1. Consort diagram of study participants

Figure 2. Changes in polysomnographic (PSG) parameters between placebo and nasal expiratory positive airway pressure (NEPAP) devices for the individual subjects (n = 14).

(A) Obstructive apnea index; (B) obstructive apnea hypopnea index; (C) percent of total sleep time with oxygen saturation (SpO2) < 90%; and (D) percent of total sleep time with end-tidal CO2 > 50 mm Hg. There was a significant decrease in the obstructive apnea index from placebo to NEPAP PSG night (p = 0.010). TST, total sleep time.

Figure 3. The bi-directional pressure versus flow characteristics of the nasal expiratory positive airway pressure (NEPAP) and placebo devices measured in vitro are shown.

NEPAP device points are shown as solid circles, and placebo points as hollow circles.