BACKGROUND:Obstructive sleep apnea (OSA) is a major problem in need of new treatment approaches. The present pilot study tests the hypothesis that the application of expiratory resistance via a nasal valve device would improve breathing during sleep in subjects with OSA and in primary snorers. METHODS:Thirty men and women were recruited from the community and from the Stanford University Sleep Disorders Clinic. Twenty-four had at least mild OSA (AHI >5), and 6 were primary snorers. Subjects underwent 2 nights of polysomnographic evaluation, one with and one without a new nasal resistance device with the order of nights counterbalanced across participants. The device consisted of a small valve inserted into each nostril calibrated to provide negligible inspiratory resistance, but increased expiratory resistance with a back pressure between 60 and 90 cm H2O*sec/Liter (at 100 mL/sec flow). Standard polysomnography was conducted to compare participants' sleep both with and without the device, with the scoring conducted blind to treatment condition. RESULTS: The apnea-hypopnea (AHI) (p < 0.001) and oxygen desaturation (O2DI) (p < 0.01) indices both significantly decreased, and the percentage of the night spent above 90% saturation (p < 0.05) significantly increased with device use. The observed amount of snoring (p < 0.001) was significantly decreased with device use, and there were no significant changes in measures of sleep architecture. CONCLUSIONS: The results of this pilot study are suggestive of a therapeutic effect of expiratory nasal resistance for some OSA patients and indicate that this technique is worthy of further clinical study.
RCT Entities:
BACKGROUND:Obstructive sleep apnea (OSA) is a major problem in need of new treatment approaches. The present pilot study tests the hypothesis that the application of expiratory resistance via a nasal valve device would improve breathing during sleep in subjects with OSA and in primary snorers. METHODS: Thirty men and women were recruited from the community and from the Stanford University Sleep Disorders Clinic. Twenty-four had at least mild OSA (AHI >5), and 6 were primary snorers. Subjects underwent 2 nights of polysomnographic evaluation, one with and one without a new nasal resistance device with the order of nights counterbalanced across participants. The device consisted of a small valve inserted into each nostril calibrated to provide negligible inspiratory resistance, but increased expiratory resistance with a back pressure between 60 and 90 cm H2O*sec/Liter (at 100 mL/sec flow). Standard polysomnography was conducted to compare participants' sleep both with and without the device, with the scoring conducted blind to treatment condition. RESULTS: The apnea-hypopnea (AHI) (p < 0.001) and oxygen desaturation (O2DI) (p < 0.01) indices both significantly decreased, and the percentage of the night spent above 90% saturation (p < 0.05) significantly increased with device use. The observed amount of snoring (p < 0.001) was significantly decreased with device use, and there were no significant changes in measures of sleep architecture. CONCLUSIONS: The results of this pilot study are suggestive of a therapeutic effect of expiratory nasal resistance for some OSA patients and indicate that this technique is worthy of further clinical study.
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