Effects of an external nasal dilator on sleep and breathing patterns in newborn infants with and without congestion.

BACKGROUND: We recently demonstrated that the use of an external nasal dilator reduced subjective snoring levels and improved sleep quality. Our study polysomnographically evaluated the effects of this device on the frequency of obstructive airway events during sleep in infants with and without congestion. METHODS: We used a crossover study to monitor 20 infants between the ages of 2 and 4 months (15 infants without congestion and 5 with congestion). Monitoring was conducted during two daytime sleep sessions in a crossover study in which infants slept with or without a cutdown version of an external nasal dilator (Breathe Right Nasal Strips, CNS, Inc., Bloomington, Minn.) in the first session with crossover to the other condition in the second session. A respiratory disturbance index consisting of apneas (pauses in respiration of at least 8 seconds) or hypopneas (decreased airflow resulting in oxygen desaturation of at least 3%) was determined. RESULTS: Babies without congestion showed a greater than 50% reduction in respiratory disturbance index from 3.2 +/- 2.8 to 1.2 +/- 1.2 events per hour (p < 0.005). Congested infants showed a decrease from 6.9 +/- 2.9 to 1.5 +/- 1.6 events per hour (p < 0.05). Babies with the greatest number of events showed the greatest improvement. CONCLUSION: The use of an external nasal dilator reduces the frequency of obstructive respiratory events in infants.

Cyclic alternating pattern sequences in non-apneic snorers with and without nasal dilation.

A study was conducted to polysomnographically evaluate the effects of external nasal dilation on sleep quality in mild snorers by examining the amount of sleep fragmentation and cyclic alternating pattern sequences (CAPS) rates. A two-night, open-label, one-way crossover polysomnographic evaluation, with and without use of an external nasal dilator, was done at the Tri-State Sleep Disorders Center in Cincinnati, Ohio. Nine snorers, polysomnographically determined to be free of clinically significant levels of obstructive sleep apnea, were studied. CAPS rates with nasal dilation were 28.4% as compared to 37.9% without nasal dilation (p < 0.05). We conclude that external nasal dilation reduces arousal instability in snorers without obstructive sleep apnea.

Computerized adjustable versus fixed NCPAP treatment of obstructive sleep apnea.

An automated positive airway pressure device that monitors respiratory patterns and provides dynamic, real-time, relational pressure has been developed for the treatment of obstructive sleep apnea (OSA). The purpose of this study was to compare self-adjusting pressure to classical nasal continuous positive airway pressure (NCPAP). Subjects were newly diagnosed patients with a minimum respiratory disturbance index (RDI) of 15 episodes per hour who had undergone NCPAP titration and been using classical NCPAP at home on a nightly basis for at least 2 weeks. Patients then underwent repeat standard polysomnographic (PSG) evaluations for 2 nights using a self-adjusting pressure mode and a standard NCPAP mode randomly assigned in a single-blind crossover fashion. Eight males and four females (n = 12), aged 48.4 +/- 12.2 years [mean +/- and standard deviation (SD)], completed the study. During initial diagnostic PSG, the RDI was 57.3 +/- 30.8 episodes per hour. The RDI and minimum oxygen saturation for both treatment nights were significantly improved from those of the diagnostic PSGs (p < 0.001). The subjects spent 63.1 +/- 34.2% of total sleep time below prescribed pressure while on automatic pressure Percent of total sleep time in stage 3/4 sleep was significantly higher during self-adjusting pressure, at 8.6 +/- 7.5%, compared to standard NCPAP, at 4.6 +/- 6.0% (p < 0.05). Computerized adjustable nasal positive airway pressure effectively controls OSA, fluidly providing the minimal pressure necessary to control respiratory events without causing sleep disruption.

A subjective evaluation of a nasal dilator on sleep & snoring.

A noninvasive external nasal dilator device was used by 20 subjects with a history of mild snoring in a 2 week open label study. The baseline assessments were obtained during the first week. Treatment effects were evaluated during the second week. Subjects were evaluated using: pre- and post-sleep questionnaires; Stanford Sleepiness Scales completed at breakfast, lunch and dinner; and post-sleep bed partner questionnaires. All twenty subjects completed the study. A significant number of subjects' scores improved for sleepiness. Mean scores for the subjective assessment for ease of breathing during sleep improved compared to baseline by 25.6%, snoring loudness improved by 34%, sleep quality improved by 21.8%, and the Stanford Sleepiness Scale revealed a 26% reduction in daytime sleepiness.