Background
Obstructive sleep apnea (OSA) is an increasingly common form of sleep-disordered breathing, with an incidence of 15% in men and 5% in women and characterized by repetitive collapse or obstruction of the pharyngeal airway during sleep. According to the Wisconsin sleep cohort study in the United States, the estimated prevalence of moderate to severe OSA increased by 14% to 55% over the past two decades
Continuous or auto-titrated positive airway pressure (PAP) is the current standard treatment; however, other therapies have emerged as alternatives. Mandibular advancement devices (or oral appliances) are currently recommended as a second line therapy; though the ability to properly track compliance, and thus efficacy, is a challenge. Surgical interventions have targeted anatomical or morphological problems in those unresponsive to standard therapies. However, the evidence supporting widespread application of surgical interventions is lacking.
Over the last decade, orofacial myofunctional therapy (OMT) has been applied to treat OSA. Both as a stand-alone therapy and in conjunction with PAP, OMT has been shown to reduce the apnea-hypopnea index, reduce snoring, and improve quality of sleep and life. However, existing OMT protocols involve methods that require specific training that is burdensome to patients.
Technology Overview
Researchers at the University of Rochester have developed a device that provides negative airway pressure (NAP) to a patient’s airway which exercises the oropharynx and increases muscle tone. The device also decreases upper airway collapsibility during sleep. Importantly, this device is similar to positive airway pressure (PAP) devices and is thus familiar to OSA patients however is meant to be used during the day. Many patients do not use CPAP machines due to the inconvenience of having to use them at night.
Use of the negative airway pressure device may lead to a patient needing a lower positive pressure on their CPAP, making the CPAP easier to use, or may obviate the need for a CPAP altogether.
Stage of Development
A prototype of the device has been made and tested on twenty subjects. Each NAP session lasted approximately 30 minutes with the treatment protocol lasting three months and it was well tolerated.
Benefits
- Day‑time therapy of OSA, which may eliminate the need for night‑time treatment with CPAP or reduce the pressure needed with the CPAP machine allowing for better compliance with treatment
- Increases airway muscle tone and decreases upper airway collapsibility by exercising the oropharynx
- Reduce the Apnea‑Hypopnea Index
- Reduce snoring
- Improve quality of sleep and improve quality of life
- Does not require specific training compared to other OMTs
- Easy to adapt to for OSA patients already familiar with CPAP devices
Applications
- Treatment of obstructive sleep apnea (OSA)
- Orofacial myofunctional therapy (OMT)