Predictors of Response to a Nasal Expiratory Resistor Device and Its Potential Mechanisms of Action for Treatment of Obstructive Sleep Apnea

Amit V. Patel, M.D.¹; Dennis Hwang, M.D.¹; Maria J. Masdeu, M.D.²; Guo-Ming Chen¹; David M. Rapoport, M.D.¹; Indu Ayappa, Ph.D.¹

¹Division of Pulmonary, Critical Care and Sleep Medicine, NYU School of Medicine, New York, NY; ²Pulmonary Department, Corporacio Park Tauli, Universitat Autonoma Barcelona, Sabadell, Spain

Study Objective: A one-way nasal resistor has recently been shown to reduce sleep disordered breathing (SDB) in a subset of patients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS). The purpose of this study was to examine characteristics predictive of therapeutic response to the device and provide pilot data as to its potential mechanisms of action.
Patients, Interventions, and Measurements: 20 subjects (15M/5F, age 54 ± 12 years, BMI 33.5 ± 5.6 kg/m²) with OSAHS underwent 3 nocturnal polysomnograms (NPSG) including diagnostic, therapeutic (with a Provent® nasal valve device), and CPAP. Additional measurements included intranasal pressures and PCO₂, closing pressures (Pcrit), and awake lung volumes in different body positions.
Results: In 19/20 patients who slept with the device, RDI was significantly reduced with the nasal valve device compared to the diagnostic NPSG (27 ± 29/h vs 49 ± 28/h), with 50% of patients having an acceptable therapeutic response. Among demographic, lung volume, or diagnostic NPSG measures or markers of collapsibility, no significant predictors of therapeutic response were found. There was a suggestion that patients with position-dependent SDB (supine RDI > lateral RDI) were more likely to have an acceptable therapeutic response to the device. Successful elimination of SDB was associated with generation and maintenance of an elevated end expiratory pressure. No single definitive mechanism of action was elucidated.
Conclusions: The present study shows that the nasal valve device can alter SDB across the full spectrum of SDB severity. There was a suggestion that subjects with positional or milder SDB in the lateral position were those most likely to respond.
Keywords: Expiratory positive airway pressure, nasal valve, obstructive sleep apnea, sleep apnea therapy

Full Text:  http://www.ncbi.nlm.nih.gov/pubmed/21344051

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