Effect of the external nasal dilator Breathe Right on snoring.
This clinical trial was designed to evaluate the efficacy of the external nasal dilator Breathe Right (nasal strip) on snoring. The assessment of snoring intensity and duration as well as the sleep quality without the Breathe Right nasal strip and after application was performed in 30 out-patients with primary habitual snoring. An all-night polysomnographic investigation including registration of a17-channel EEG, EMG, respiration parameters such as breathing efforts and nasal/oral air flow, snoring vibrations, ECG, oxygen saturation, etc. was conducted in the sleep laboratory of Pro Science Private Research Clinic GmbH. The drug-free strip Breathe Right was able to reduce the maximum snoring intensity (maximum snoring vibration) throughout the night (p = 0.02, sign test), especially during the superficial sleep (sleep stage 1 and 2). The snoring intensity remained almost unchanged during slow wave sleep (SWS) and REM. In comparison with the baseline the maximum snoring intensity was reduced during the second treatment night in 22 of the 30 investigated snorers. The differentiation between snorers with and without obstructive sleep apnea and between mild and heavy snorers allowed to state that especially the snorers without apnea and the time in bed, TIB) can achieve a reduction of the maximum snoring intensity using the strip. Moreover, the number of snores per hour TIB (snoring index, SI) was reduced after application of the nasal strip for the snores with an intensity greater than 20 dB (p = 0.02, sign test). The sleep architecture remained almost unchanged, although the nasal strip led subjectively (SF-A questionnaire) to an improvement of sleep quality. The overall estimation of the subjective efficacy rating revealed that 17 of 30 patients (second treatment night) needed a certain period of time to accustom to the nasal strip. After that they could breathe easily, slept well and felt recuperated in the following morning. No adverse events were observed after adhesion of the nasal strip, except for one patient, who had the sensation as if they needed to sneeze for a short time after the first application of the nasal strip. Consequently, Breathe Right is a safe and easily applied noninvasive method to reduce the maximum snoring intensity, especially in habitual mild snorers.
Pro Science Private Research Clinic GmbHmed. Forschung und Entwicklung, Kurt-Schumacher-Strasse 9, D-35440 Linden, Germany.
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A
Todorova
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R
Schellenberg
H C
HC
Hofmann
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W
Dimpfel
D000328:Adult; D004106:Dilatation / Q000295:instrumentation; D005260:Female; D006801:Humans; D007866:Leg; D008297:Male; D009068:Movement; D009666:Nose / Q000503:physiopathology; D017286:Polysomnography; D015656:Respiratory Mechanics; D012890:Sleep / Q000502:physiology; D012891:Sleep Apnea Syndromes / Q000503:physiopathology / Q000628:therapy; D012894:Sleep Stages / Q000502:physiology; D012913:Snoring / Q000503:physiopathology / Q000628:therapy*; D011795:Surveys and Questionnaires; D014732:Vibration