Clinical Research

Stenting the nasal airway for maximizing inspiratory airflow: internal Max-Air Nose Cones versus external Breathe Right strip.

 2011 JUL-AUG;25(4):249-51. DOI: 10.2500/AJRA.2011.25.3621.

Abstract

BACKGROUND:

Several nasal dilator devices designed to stent the anterior nasal airway to increase peak nasal inspiratory flow (PNIF) currently exist; however, comparisons of such devices are limited. This study was designed to compare the efficacy of two different nasal dilator devices, an internal device (Max-Air Nose Cones; Sanostec Corp., Beverly Farms, MA) and an external device (Breathe Right nasal strip; GlaxoSmithKline, Brentford, Middlesex, U.K.) on stenting of the anterior nasal airway to maximize PNIF.

METHODS:

Repeated measurements of PNIF were obtained in 30 individuals noting complaints of sleep-disordered breathing due to nasal breathing discomfort and nasal airway obstruction, both with and without the two different nasal dilator devices.

RESULTS:

A one-within analysis of variance (ANOVA) was performed among the three conditions (control, Max-Air Nose Cones, and Breathe Right nasal strip), and a statistically significant effect was found (F[2,58] = 298.13; p< 0.00001). Tukey post hoc contrasts revealed that the control condition PNIF (66.07 L/min) was significantly lower than both the Max-Air Nose Cones (138.73 L/min) and the Breathe Right nasal strip (102.17 L/min) conditions. The Max-Air Nose Cone increased inspiratory airflow by 73 L/min, or a 110% improvement over baseline. In addition, the Max-Air Nose Cone condition PNIF was significantly higher than both the control condition and the nasal strip condition.

CONCLUSION:

Although both the Max-Air Nose Cones and the Breathe Right nasal strips increased PNIF from baseline, the Max-Air Nose Cones showed significantly greater efficacy at stenting the anterior nasal airway, providing twice the improvement in PNIF over baseline than did the Breathe Right nasal strips.

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Comparison of zzoma® positional sleep therapy in patients with OSA

Obstructive Sleep Apnea (OSA) Syndrome is highly prevalent, affecting 2% of women and 4% of men in the general population. Recent studies have identified OSA as an independent risk factor for a number of cardiovascular diseases, including hypertension, stroke, congestive heart failure and coronary artery disease. CPAP is the most common treatment for patients with OSA, as it has been shown to be efficacious. However, compliance with CPAP therapy is poor, with studies demonstrating compliance rates of less than 50%. The treatment is often uncomfortable and burdensome to the patient, with reported intolerance to the pressure, nasal congestion, claustrophobia or discomfort related to the mask. Other therapeutic options include surgical intervention of the upper airway, weight loss, the use of an oral appliance, and when indicated, positional therapy.

Recent data has identified that positional obstructive sleep apnea, where patients have the majority of their sleep-disordered breathing events when lying supine, is quite prevalent in patients with mild and moderate OSA. Using the definitions of the American Academy of Sleep Medicine (AASM), Mador et al found that 50% of patients with mild OSA (apnea-hypopnea index [AHI] of 5-15 events/hr) and 19% of patients with moderate OSA (AHI of 15-30 events/hr) have positional OSA. Again, using the AASM definition of normal as being < 5 events/hr, these patients when in the non-supine position would decrease their AHI to < 5 events/hr.

As a result, we evaluated the effects of a new positional device (Zzoma® Positional Device) in patients with positional OSA and compared it to conventional CPAP therapy, specifically utilizing definitions of success as a normalization of the AHI to < 5 events/hr. The Zzoma® Positional Device has been designed along the “ball in the backpack” concept that has been used in previous studies. However, the shape and the design of the Zzoma® Positional Device has been improved over this simplistic concept in order to maximize effectiveness and comfort in keeping the patient sleeping in the lateral position.

There were 4 major findings in this study:

1. In patients with positional OSA, Zzoma® is equivalent to CPAP therapy at normalizing the AHI to less than 5 events/hr in addition to decreasing the AHI by over 50.

2. Zzoma® is similar to CPAP therapy in regards to effects on sleep quality and nocturnal oxygenation.

3. There is minimal night-to-night variability in the non-supine AHI in patients with positional OSA.

4. Zzoma® is effective at maintaining patients in the non-supine position throughout the night.

Click Here to download the full clinical study.

National Heart Lung and Blood Institute: What Is Sleep Apnea? Sleep apnea often goes undiagnosed. Doctors usually can’t detect the condition during routine office visits. Also, there are no blood tests for the condition. View an animation that shows how air flow to the lungs can be blocked, causing sleep apnea. Learn about the side effects of untreated sleep apnea.  

JCSM: Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. Guideline Objective: This guideline is designed to assist primary care providers as well ass sleep medicine specialists, surgeons, and dentists who care for patients with OSA by providing a comprehensive strategy for the evaluation, management and long-term care of adult patients with OSA.  

The 2009 AASM guidelines relating to treatment of positional therapy state:

“Positional therapy, consisting of a method that keeps the patient in a non-supine po­sition, is an effective secondary therapy or can be a supplement to primary therapies for OSA in patients who have a low AHI in the non-supine versus that in the supine position (Guideline).21 Because not all patients normalize AHI when non-supine, cor­rection of OSA by position should be documented with PSG before initiating this form of treatment as a primary therapy (Consensus). A positioning device (e.g., alarm, pillow, back­pack, tennis ball) should be used when initiating positional therapy (Consensus). To establish the efficacy of a positioning device in the home, providers should consider use of an objec­tive position monitor (Consensus). Treatment specific outcome indicators to monitor with therapy include: self-reported com­pliance, objective position monitoring, side effects, and symp­tom resolution (Consensus).”