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Science Behind the Sleep - Zzoma Positional Sleep Belt

Case Studies of our Sleep without Snoring products

Whether through in-house clinical trials, scientific case studies, or information gathered from medical journals; Shoreline Medical Services only provides better sleep products backed by real data that our customers can view for themselves.

Zzoma Positional Sleep Therapy (Sleep Belt) - 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 sleeping device (Zzoma Positional Sleeping 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 (Click HERE to view/download the full clinical study .pdf document):

 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.

 

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