Trends in Sleep Apnea Treatment

Apnea is a serious sleep disorder in which breathing stops and starts often during sleep, it results in low oxygen levels in the blood and the patient awaken several times throughout the night. Undiagnosed or untreated sleep apnea can lead to serious complications such as heart attack, stroke, glaucoma, diabetes, cancer, and cognitive and behavioral disorders. Obesity, smoking and drinking alcohol are common factors leading to sleep apnea disorder. The involuntary pause in breathing can result either from a blocked airway or a signaling problem in the brain, based on these criterions; sleep apnea is classified as obstructive sleep apnea (OSA), central sleep apnea (CSA) and complex sleep apnea syndrome (ComSAS). There are three types of obstructive sleep apnea, mild OSA patient experiences 5-14 episodes of interruptions in breathing in an hour, moderate OSA patient experiences 15-30 episodes of interruptions in breathing in an hour and severe OSA patient experiences 30 or more interruptions in breathing in an hour.

The sleep apnea can be diagnosed using various devices such as polysomnography, respiratory polygraph, and pulse oximeter based at a sleep center, or actigraphy and other sleep screening devices such as NightOwl and WatchPAT based at the residence of the patient. Among these, polysomnography is the common and major diagnostic device. Sleep apnea can be treated with Positive Airway Pressure (PAP) devices, Adaptive Servo-Ventilation (ASV) this device is particularly used for central sleep apnea, Oral Appliances and implantable neurostimulation devices. However, there are significant unmet needs such as the need for the development of management strategies of sleep apnea to prevent the development of co-morbidities and need to develop diagnostic and treatments that are more compatible, patient-friendly and are not cumbersome to use.

PAP devices are of three types such as continuous positive airway pressure (CPAP), Automatic positive airway pressure (APAP) and Bi-level positive airway pressure (BiPAP). CPAP device blows a constant stream of pressurized air into the airway continuously to keep the airways open. With CPAP, the level of pressure delivered to the airway is the same during both inhalation and exhalation. This is the first PAP device used for the treatment of sleep-disordered breathing, as a simple way to support patients with sleep apnea. The APAP devices automatically adjust the minimum amount of pressure required by the patient to maintain an unobstructed airway by measuring the resistance in the patient’s breathing. After a Home sleep test on the patient, the amount of pressurized air required to keep airways clear of obstructions can be determined. Since CPAP machines can only be set to one pressure setting that remains consistent throughout the night, APAP fills this drawback. Variable positive airway pressure (VPAP) or bi-level positive airway pressure (BPAP) is a newer type of device that reduces the amount of pressure when a person breathes out with an electronic circuit that monitors the patient’s breathing.

Since some patients are non compliant to the PAP devices because it is user unfriendly and bulky and patient feel uncomfortable, demand for other types of sleep apnea treatment devices is increasing, oral appliances, sleep positioning devices, and implantable devices are some of the devices used for the treatment of sleep apnea. Oral appliances are effective devices for the treatment of snoring and obstructive sleep apnea (OSA), oral appliances are worn only during sleep and it fits like a sports mouthguard or an orthodontic retainer. It supports the jaw in a forward position to help maintain an open upper airway. The advantages of oral appliances are, they are comfortable, easy to wear, quiet, portable and convenient for travel. There are two types of oral appliances such as Mandibular repositioning devices (MRD) and tongue retaining (stabilization) devices (TRD). Sleep Position device is a small and flat device, this ensures that sleep is not disturbed and allows the patient to easily move from left to right side without any movement restrictions. The device vibrates during sleep at a level which is easily detected by the body without disturbing sleep, it automatically determines the level of vibrations based on sleep patterns to remain effective in the long-run.

Implantable devices are of two types one is Phrenic Nerve Stimulator (PNS), which is a surgically implanted device that also known as diaphragm pacing devices used to stimulate the phrenic nerve. The use of the device is recommended for patients suffering central sleep apnea. The other one is Hypoglossal Nerve Stimulator (HGNS) an implantable medical device that works to reduce the occurrence of Obstructive Sleep Apnea (OSA) by electrically stimulating the hypoglossal nerve to the tongue. The stimulation does not cause pain. It can effectively treat moderate to severe OSA.

Increase in the sleep apnea population, product approvals, funding and investments to develop innovative products and technological advancements are the driving factors of the market. OSA is the most common disorder in the U.S. for instance, in 2019, an estimated 24.7 million U.S. adults were suffering from obstructive sleep apnea. Globally, the prevalence of sleep apnea impacts more than 807.3 million that is 8 times greater than WHO estimations as of 2007 worldwide.

Major players in sleep apnea global market are ResMed Inc. (U.S.), Koninklijke Philips N.V. (New Zealand), Fisher and Paykel Healthcare Medical Corporation (Switzerland), Apex Medical Corporation (Taiwan), Nihon Kohden Corporation (Japan) Natus Medical Inc.. (U.S.), Inspire Medical Inc. (U.S.), Drive Medical (Drive DeVilbiss Healthcare) (U.S.), and SomnoMed (U.S.).

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