FIELD

The present disclosure is directed to systems and methods for treatment of obstructive sleep apnea (OSA).

BACKGROUND

Obstructive sleep apnea (OSA) is a condition that can include temporary diminutions or cessations of breathing caused by repetitive collapse of the upper airway (UA) during sleep. OSA is a common disorder in which the muscles of the airway, which normally relax during sleep, fail to provide sufficient dilatory force to balance the contractive force from inspiratory activity. This force imbalance can collapse the UA either partially or completely, thereby preventing sufficient air from reaching the lungs. These pauses in breathing lead to blood oxygen desaturation and induce neurological arousal resulting in sleep disruption and fragmentation. The cycle of airway collapse and arousal can repeat hundreds of times per night.

OSA affects between 18 and 22 million Americans per year and is associated with physiological and psychological problems. OSA results in excessive daytime sleepiness, fatigue, memory impairment, and reduced reaction time, increasing the risk for motor vehicle and workplace accidents. In addition, OSA sufferers can face increased cardiovascular risk including hypertension, heart disease, and stroke. OSA has been recently linked to increased cancer incidence and mortality, presumably through hypoxia-induced angiogenesis. According to the National Sleep Foundation, 80% of the cases remain undiagnosed.

Existing treatments for OSA can include lifestyle modifications such as weight loss, position restriction, avoidance of muscle relaxants such as alcohol and benzodiazepine drugs, and oral appliances including mandibular advancement devices and tongue retaining devices. OSA is also treated through surgery. The most widespread and generally effective treatment for OSA, however, remains the use of various devices for maintaining positive airway pressure (PAP) such as Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiPAP), and Autotitrating (AutoPAP) devices. CPAP and related treatments are costly and cumbersome. 40-60% of patients prescribed CPAP fail to adhere to the treatment. Patients cite comfort and lifestyle factors (sensation of claustrophobia, dry mouth, ill-fitting mask, and lack of portability of the system precluding use during travel) as reasons for abandoning treatment. Among older men, Benign Prostatic Hypertrophy (BPH), with accompanying nocturia, has also been associated with noncompliance with CPAP. Poor compliance with CPAP is prompting the search for alternative forms of treatment for OSA.

SUMMARY

Disclosed herein are systems and methods to train the Genioglossus (GG) muscle. GG muscle makes up most of the body of the tongue and is a major UA dilator, responsible for opposing the collapsing force in pharynx upon inspiration. Systems include, deploying a tongue-training device to strengthen the GG muscle, for the latter to dilate the pharyngeal pathway and thus prevent UA collapse.

According to one aspect of the disclosure, a device includes a mouthpiece. The mouthpiece includes a force transducer and a pusher plate. The pusher plate can be coupled with the force transducer. The pusher plate can be configured to transfer a force applied to the pusher plate to the force transducer. The device can also include a control module that includes at least one processor that is configured to receive a signal from the force transducer. The signal can indicate the force applied to the pusher plate.

The force transducer can be a piezoresistive compression load cell. The force transducer can have a dynamic range of between about 0 and about 25 lbf. A housing of the mouthpiece can include at least one of DELRIN, TEFLON, or polylactide plastic.

The mouthpiece can include one or more grooves configured to receive a user's tooth. The one or more groove can be angled between about 0 degrees and about 20 degrees. The pusher plate can be removable from the mouthpiece. The pusher plate can include a textured surface.

According to another aspect of the disclosure, a mouthpiece can include a force transducer and a pusher plate coupled with the force transducer. The pusher plate can be configured to transfer a force applied to the pusher plate to the force transducer.

The mouthpiece can include one or more grooves configured to receive a user's tooth. The pusher plate can include a textured surface. The mouthpiece can be disposable.

According to another aspect of the disclosure, a method can include providing a mouthpiece. The mouthpiece can include a force transducer and a pusher plate that is coupled with the force transducer. The method can also include providing a control module coupled with the mouthpiece. The method can include transferring, by the pusher plate, a force applied to the pusher plate to the force transducer. The method can include converting, by the force transducer, the force to a signal. The method can also include receiving, by the control module, the signal.

The force transducer can be a piezoresistive compression load cell. The force transducer can have a dynamic range of between about 0 and 25 lbf. A housing of the mouthpiece can include at least one of DELRIN, TEFLON, or polylactide plastic. The mouthpiece can include one or more grooves configured to receive a user's tooth. The one or more grooves can be angled between about 0 degrees and about 20 degrees. The pusher plate can be removable from the mouthpiece. The pusher plate can include a textured surface.

