What is Obstructive Sleep Apnea?

Obstructive sleep apnea, or OSA, and moderate to severe snoring arises from what is basically an anatomical situation in the soft pallet. While there are many factors that contribute to OSA and snoring, the major contributor to OSA and snoring, is the tongue.  During sleep the patient's tongue falls back against his or her soft palate, and the soft palate and uvula fall back against the back of the throat, effectively closing the airway.  When the sleeper expands the chest to inhale, no air enters the lungs.  Breathing pauses can last from a few seconds to minutes. They may occur 30 times or more an hour. Typically, normal breathing then starts again, sometimes with a loud snort or choking sound.

Obstructive Sleep Apnea, OSA and snoring carry many significant health risks.  Untreated OSA and snoring are serious and potentially life-threatening conditions and are known to be contributors to and increase the risk of the following diseases:  High Blood Pressure, Heart Attack, Stroke, Obesity, Diabetes, Atrial Fibrillation, Motor Vehicle Accidents, Arthroplasty, Metabolic Syndrome, Gastroenterology and Hepatology, Parkinson's Disease, and Alzheimer's Disease.  According to the NIH, Hispanics, Asians and African Americans are at greater risk than Caucasians.

Surgical procedures are painful, invasive and do not always provide the desired effect.

Sleep Apnea, (OSA), and moderate to severe snoring often go undiagnosed.  Doctors usually can’t detect the condition during routine office visits.  Also, no blood test can help diagnose the condition.

Surveys reveal that about one-half of all adults snore, and 50% of these adults do so loudly and frequently.

According to the National Institute of Health (NIH), sleep-disordered breathing, including obstructive sleep apnea (OSA), affects about 84% of people who snore and about half of these suffer from OSA. 

About 10-15% of children snore on a regular basis.  Studies show that they may suffer from hyperactivity, aggressive behavior and score lower on tests and exams that measure intelligence, memory and attention span. 

A significant percentage of chronic snorers have a more serious condition called Obstructive Sleep Apnea or OSA.  The total number of people in the US with OSA ranges from 21 to 48 million people and is significantly under diagnosed.  Worldwide this number is many times greater. 

                             CLINICAL EFFICACY

PIVOT SOLUTION has been clinically tested and has proven more effective than the most commonly prescribed mandibular advancement appliances.  Two separate sleep studies, (polysomnography) have been conducted and the results confirm PIVOT SOLUTION's effectiveness of air flow and oxygenation during sleep.  The first half of the night was spent without the PIVOT SOLUTION device.  The second half of the night was performed with the PIVOT SOLUTION device.  The sleep studies showed that the PIVOT SOLUTION device fully eliminated snoring and sleep apnea.  Table 1: The results show a dramatic improvement in the AHI(Apnea Hypopnea Index). In both cases the AHI was reduced by almost 90%.  Clinical Results of Competitor Mandibular Advancement Devices are shown Table 2 (Below), which indicates that these products only have about a 50% effectiveness.

(Studies available upon request.)

Explanation of the above chart:

(AHI) Apnea Hypopnea Index, is the number of apneas or hypopneas recoded during the study per hour of sleep.  It is generally expressed as the number of events per hour.  Based on the AHI, the severity of OSA is classified as follows:

None/Minimal: AHI < 5 per hour (as the results of the PIVOT SOLUTION indicate a score of 2.4 and 2.9 and "Fully Treated".  Compare these results to the results from the two leading appliances prescribed for OSA.

Mild: AHI > or less, but < 15 per hour --  Moderate: AHI > or less, 15, but < 30 per hour  --  Severe: AHI > or less 30 per hour

Please note the significant difference in AHI with PIVOT SOLUTION and Competitor Mandibular Advancement devices.  Also note the significant difference in Percentage Improvement between PIVOT SOLUTION and the Competitors Fully Treated.