Nasal Dilator

It is usually amusing to hear a person snore. In fact, any internal nasal dilator without a positive retaining means, as disclosed herein, will fall out of the nose in practical use, according to extensive evaluation of the dilator of the present invention; in this event, the dilator would be inoperative, or at least not useful for the purpose intended.
Metabolic gas analysis was not performed in this study because the more practical comparison we were seeking (LT) did not require this measurement and because we lacked the specific mask that would allow for oronasal breathing during the oxygen consumption test.



7. A nasal dilator as defined in claim 5, and said flexible strip also including at least one non-adhesive segment between said two end-adhesive segments, for enabling the wearer to install said dilator without the fingers contacting said two adhesive segments and to determine the portion of the nose subjected to said end adhesive segments.
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There is only a handful of studies that look at the benefits of using internal nasal dilators 6. Max-Air Nose Cones, Airmax nasal dilators and NoZovent clips have been shown to increase nasal airflow, with both NoZovent and Max-Air performing better than external nasal strips 5.
Participants who met the entrance criteria, who were currently suffering from nasal congestion every night or almost every night, reported trouble with their sleep and had baseline nasal openness scores at bedtime during the qualification phase of ≤ 70 on a 100-point VAS on at least four of seven qualification nights were randomized to one of two treatments for use at home.
On the ad hoc analysis, in the overall ITT population, the butterfly prototype and BRNS clear strips produced significantly (P < 0.05) greater improvement from baseline to day 7 than the placebo strip for PIRS nighttime sleep parameters (LS mean changes − 2.03, − 2.11, and − 1.05, respectively) and quality of life (− 2.68, − 3.12, and − 1.26, respectively).

Based on the findings of a single study ( 12 ), it has been suggested that nasal strips can help an athlete do the same amount of exercise using less energy” ( 8 ). The rationale is that if airway resistance is reduced, then respiration is easier; thus, the metabolic cost of ventilation is lower.
The dilator illustrated herein comprises a thin U or V-shaped member, preferably a spring (hereinafter referred to as UV-spring); the preferred forms of the invention include thin pads at each spring-end for soft contact on the nasal surfaces when the two spring-ends are inserted, each in one of the two nostrils to expand the nasal opening.

While our study was limited to 2 weeks, a prior randomized, controlled 4-week study of nasal dilator strip use by nonobese patients with mild to moderate sleep-disordered breathing and sleep-maintenance insomnia (N = 91) found that the strip was associated with large improvements in the severity of insomnia and sleep quality, and moderate improvements in sleepiness and quality of life scores on patient-reported outcome scales (Insomnia Severity Index, PSQI, FOSQ, and Quality of Life Enjoyment and Satisfaction Questionnaire) 15 While longer-term follow-up is lacking, the results of the current trial and the 4-week study show no indication that the potential benefits of nasal dilator strips wane over time with nightly use.
According to snorers in a market-study, almost all of the people in the study have used external dilators now on the market, and they all advised that these dilators provide only a slight improvement in breathing (because of the inherent limitation explained above).

In this randomized, double-blind study, subjects with chronic nasal congestion and sleep difficulties were assigned a BRNS clear strip, an asymmetric butterfly prototype, or an asymmetric butterfly placebo strip without springs, to use nightly for 2 weeks.