Iltifat Husain MD contributed to this piece 

For patients suffering from sleep apnea, CPAP can be daunting and difficult. This leads to noncompliance resulting in poor quality treatment.  When asking patient’s about their CPAP compliance one of the most difficult things to manage is when you hear about noncompliance due to “difficulty with the mask” — even after various iterations of devices are tried.

Noncompliance is a serious issues and can manifest into worsening cardiopulmonary pathology and avoidable and costly trips to the Emergency Room.

These patients could potentially find relief in a recently FDA approved implantable sleep apnea treatment device.

The Inspire Upper Airway Stimulation device electrically stimulates a branch of the hypoglossal nerve that innervates the genioglossus muscle.

The stimulation is synchronized with the patient’s natural ventilation using a sensing lead in the fourth intercostal space. The device can be activated by the patient each night at bedtime using a remote.

A study that analyzed the efficacy of the device was published in the New England Journal of Medicine in January. Researchers selected patients that had compliance issues with CPAP.

implant diagram

All 126 patients selected had the device implanted and used it for 12 months. Following the first 12 month phase, the first 46 consecutive patients that responded to therapy were randomly divided into two groups. One group continued therapy with the device while the other group stopped therapy for 7 days.

The primary outcome measures were the Apnea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI). The AHI is the number of apnea or hypopnea events per hour and ODI is the number of times that the blood oxygen level dropped by at least 4% per hour. Secondary outcome measures included surveys to assess daytime function.

outcomes graphs

The median AHI and ODI scores after 12 months showed 68% and 70% decreases respectively. In the second phase of the study, the group that stopped treatment for 7 days showed increases in both scores returning to near-baseline.

Secondary outcome measures demonstrated decreases in the effects of sleep apnea and improved quality of life. Less than 2% of patients experienced severe, procedure-related adverse effects. The Inspire Upper Airway Stimulation device is expected to be available later this year. At this point, a price point has not been set.

Although long term outcomes have not been studied yet, these promising results demonstrate an exciting leap forward in the treatment of sleep apnea. In addition to making it easier for patients to comply with treatment, this implantable device allows patients greater mobility. Patients will be able to travel more easily and sleep more comfortably without worrying about needing a bulky device to help them breathe through the night.

Sources: New England Journal of Medicine, Inspire Upper Airway Stimulation