A neurostimulation device that offers sufferers from obstructive sleep apnoea (OSA) an alternative to continuous positive airway pressure (CPAP) therapy has gained CE Mark approval.

The Hypoglossal Nerve Stimulation (HGNS) system from US company Apnex Medical has been approved for sale in Europe based on the results of clinical studies in the US and Australia that showed the device to reduce the symptoms of OSA.

OSA – an inability to breathe during sleep – is estimated to affect 100 million people worldwide. It causes excessive daytime fatigue and increases the risk of stroke, heart disease and death.

CPAP therapy is the current standard for OSA, but many patients cannot tolerate it or comply poorly with it. The HGNS system offers a radically different approach: an implantable therapy that activates the muscles in the upper airway.

Implanted in the shoulder, the HGNS system measures the patient’s breathing during sleep and delivers mild electrical pulses to the hypoglossal nerve (which controls the tongue) to keep the airway open.

The system can be programmed to operate only when the patient is asleep, or be turned on and off with a hand-held switch.

The Apnex Clinical Study, a randomised clinical trial, is ongoing in the USA, Europe and Australia. It is designed to test the safety and effectiveness of the HGNS therapy in patients with OSA in whom CPAP therapy has not been effective.

“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnoea and is a key milestone for our company,” said Chas McKhann, President and CEO of Apnex Medical. “We are excited to bring this innovative new therapy to Europe.”

Based in Minnesota, USA, Apnex Medical specialises in innovative therapies for sleep-disordered breathing.

A new CPAP (continuous positive airway pressure) device from Philips Respironics could enable people with obstructive sleep apnoea (OSA) to manage their own condition more effectively.

The new REMstar Pro (pictured) with AutoIQ is able to track the patient’s sleep breathing over several nights, establish or readjust to a set airway pressure, and check back periodically to adjust the pressure as needed – without clinician intervention.

The first phase of the AutoIQ mode, Auto-Trial, uses an algorithm for a total of 30 days to establish the patient’s treatment needs. At the end of the phase, the device analyses the data to identify and deliver the best airway pressure for the patient.

Following that, Auto-Check checks back every 30 hours to see how the patient is progressing and to automatically adjust the pressure if needed.

Auto-Trial days can be saved to reassess therapy at a later date if the patient’s physical condition or sleeping environment changes.

Throughout the process, AutoIQ keeps the care team informed of the patient’s sleep breathing performance and CPAP compliance.

“REMstar Pro with AutoIQ demonstrates our ongoing pledge to providers and their patients to be their ally in better sleep and breathing,” said John Frank, General Manager for Sleep and Respiratory Care, Philips Home Healthcare Solutions.

“By providing intelligent solutions and advancements in technology, we are shaping the future of sleep therapy.”

Philips Respironics is a unit of Royal Philips Electronics of the Netherlands, a market leader in cardiac care, acute care and home healthcare.

A nighttime-breathing machine and a mouthpiece intended to be worn at night have both been shown to be effective in combatting sleep apnea.

The continuous positive airway pressure (CPAP) machine pumps air through a mask while the patient is asleep. The mask pushes a steady stream of air through the nose to keep the throat and airway open.

This improves airflow in the patients’ lungs, according to a new report funded by HHS’ Agency for Healthcare Research and Quality (AHRQ) in the US.

Another treatment, a mouthpiece called a mandibular advancement device (MAD) can also be effective, the report discovered.

Carolyn M. Clancy, Director of AHRQ, stated: “These guides and this new report will help patients and their doctors understand what treatment options might be best for them.”

Many kinds of CPAP machines and masks exist; some fit over the nose, and others cover both the nose and mouth.

Sleep apnea is a disorder that disrupts sleep for an estimated 12 million Americans, with millions more undiagnosed.