Newly FDA-cleared device treats sleep apnea, tracks patient compliance

SomnoDent--Courtesy of Braebon

The inconvenience of sleep apnea devices makes patient compliance tough to achieve, particularly over the long term. But now a new oral device to treat mild and moderate sleep apnea incorporates a wireless microrecorder to track and transmit patient usage. The device, SomnoDent, is expected to help level the playing field for usage tracking between CPAP machines and oral devices.

This is the first oral device cleared by the FDA to include compliance recording technology, according to its maker Australian micro-cap SomnoMed. The company partnered with Braebon to use its DentiTrac technology in the SomnoDent oral device.

The companies expect that improved patient compliance will translate into more effective treatment.

"Our patients subjectively report that they use their SomnoDent devices at very high rates of compliance, but this is a way for physicians and dentists to reliably make sure that we are actually reaching those levels of compliance, because we know that the more compliant the patient is, the more effective the treatment," said SomnoMed CMO Dr. Jagdeep Bijwadia in a statement.

SomnoDent is an oral device worn during sleep that moves the jaw forward slightly. This prevents the collapse of the airway, thereby reducing sleep apnea. The DentiTrac technology tracks and analyzes when a patient is wearing their device and can transmit data to a HIPAA-secure cloud portal to be accessed by physicians.

CPAP, which involves a breathing mask and device, is a common prescription for sleep apnea--but SomnoMed argues that this is at least in part because until now oral devices have not offered any compliance assessment, whereas CPAP machines typically do. It expects its oral device to be an attractive alternative for patients who have found they can't tolerate a CPAP machine.

"The ability to objectively measure patient compliance is an important feature for COAT (Continuous Open Airway Therapy), when compared to other treatment modalities," said SomnoMed executive chairman and CEO Dr. Peter Neustadt in a statement. "Physicians and payers have told us that they want to have evidence that patients are wearing their SomnoDent and receiving treatment as prescribed."

- here is the release

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