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Randomized Controlled Trial
. 2021 Apr;18(4):668-677.
doi: 10.1513/AnnalsATS.202009-1161OC.

PAP Adherence and Nasal Resistance. A Randomized Controlled Trial of CPAPflex versus CPAP in World Trade Center Responders

Jag Sunderram  1 , Indu Ayappa  2 , Shou-En Lu  3 , Han Wang  3 , Kathleen Black  4 , Akosua Twumasi  2 , Haley Sanders  2 , Denise Harrison  5 , Iris Udasin  4 , Nishay Chitkara  5 , Rafael E de la Hoz  6 , Jeffrey L Carson  1 , David M Rapoport  2
Affiliations
Randomized Controlled Trial

PAP Adherence and Nasal Resistance. A Randomized Controlled Trial of CPAPflex versus CPAP in World Trade Center Responders

Jag Sunderram et al. Ann Am Thorac Soc. 2021 Apr.

Abstract

Rationale: Continuous positive airway pressure (CPAP) adherence is often poor in obstructive sleep apnea (OSA) and may be influenced by nasal resistance. CPAP with a reduction of expiratory pressure (CPAPflex) may reduce discomfort in those with high nasal resistance and improve adherence in this subgroup.Objectives: To evaluate the association of positive airway pressure (PAP) treatment adherence to nasal resistance and examine if CPAPflex improves adherence over CPAP in subjects with high nasal resistance.Methods: A randomized double-blind crossover trial of 4 weeks each of CPAPflex versus CPAP in subjects exposed to World Trade Center dust with OSA stratified by nasal resistance, measured by 4-Phase Rhinomanometry.Results: Three hundred seventeen subjects with OSA (mean, apnea-hypopnea index with 4% O2 desaturation for hypopnea = 17 ± 14/h) were randomized. Overall, PAP adherence was poor, but adherence to CPAP (n = 239; mean hours per night [95% confidence interval (CI)]), 1.97 h (1.68 to 2.26) was greater than adherence to CPAPflex (n = 249; 1.65 h [1.39 to 1.91]; difference of 0.31 h [0.03; 0.6]; P < 0.05). Contrary to our hypothesis there was no correlation between nasal resistance and adherence to CPAP (r = 0.098; P = not significant) or CPAPflex (r = 0.056; P = not significant). There was no difference in adherence between CPAP and CPAPflex (mean Δ hours [95% CI]) in subjects with low resistance (0.33 h [-0.10 to 0.76]) or high nasal resistance (0.26 h [-0.14 to 0.66]). No significant differences were observed in any of the secondary outcomes between PAP modes.Conclusions: Contrary to expectations, our data do not show better adherence to CPAPflex than to CPAP in subjects with high or low nasal resistance and do show clinically insignificant better adherence overall with CPAP.Clinical trial registered with www.clinicaltrials.gov (NCT01753999).

Keywords: obstructive; reduced expiratory pressure; sleep apnea; sleep-disordered breathing; therapy.

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Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials diagram of randomized controlledran trial. CPAP = continuous positive airway pressure; CPAPflex = CPAP with a reduction of expiratory pressure; OSA = obstructive sleep apnea; WTC SNORE = Role of Nasal Pathology after OSA in World Trade Center Responders.
Figure 2.
Figure 2.
(A) Scatter plot showing the relationship between logTNR and adherence to continuous positive airway pressure (CPAP) (solid circles) and CPAP with a reduction of expiratory pressure (CPAPflex) (open circles) in all subjects. (B and C) The same data are shown as in A but are separated by CPAP (B) and CPAPflex (C). No relationship was observed between nasal resistance and positive airway pressure adherence. TNR = total nasal resistance.
Figure 3.
Figure 3.
Scatter plot of logTNR and adherence in nonrejectors (i.e., after excluding rejectors) of positive airway pressure. Continuous positive airway pressure (CPAP) (solid circles) and CPAP with a reduction of expiratory pressure (CPAPflex) (open circles). Higher TNR shows a trend for greater adherence/use for CPAP (r = 0.16; P = 0.14) and CPAPflex (r = 0.21; P = 0.05). TNR = total nasal resistance.
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