Myofunctional training with negative airway pressure for obstructive sleep apnea
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Publication Number
US-12508382-B2
Publication Date
2025-12-30
Expiration Date
Abstract
The present invention provides a method and apparatus for treating a subject suffering from obstructive sleep apnea (OSA). In one embodiment, the method of the present invention is configured to deliver negative airway pressure to a subject's airway to strengthen the airway muscle tone.
Core Innovation
The disclosed invention relates to an OSA therapy system and protocol that uses negative airway pressure (NAP) applied as quantified orofacial/myofunctional training. A face mask or mouthpiece forms a chamber between the mask and the subject’s face, and a vacuum pump creates a pressure in the chamber of about −1 to −125 cm H2O. The system includes components to measure airflow and/or pressure within the chamber.
The protocol includes a dosing concept using a one-repetition maximum (1RM) defined as the maximum negative pressure tolerated by the subject for one breath. A subject is exposed to a set of random negative pressures in a random sequence, and a 1RM is calculated across the random negative pressures. A target negative pressure is then provided to the subject based on the calculated 1RM.
Training is performed by repeated exposure at the measured 1RM across multiple sets with rest intervals, together with periodic re-evaluation of 1RM after a first or second month. The disclosed protocol is delivered over a multi-week schedule, and pilot experimental outcomes are reported, including subject completion of the protocol, tolerance outcomes, and measures including apnea-hypopnea index (AHI) and oxygen saturation nadir.
Claims Coverage
The partial claim set includes two independent claims, one system claim and one method claim. Across these claims, the inventive features focus on generating random negative pressures in a sealed chamber and using the resulting responses to compute a 1RM, and on using the computed 1RM to set a target negative pressure for treating obstructive sleep apnea.
Sealed mask chamber with vacuum pump pressure generation
A mask placed sealingly over a subject’s face forms a chamber between the mask and the subject’s face, with an inlet port receiving breathable gas and a vacuum pump capable of creating about −1 to −125 cm H2O in the chamber.
Random negative pressures with computing 1RM and target pressure
A computing device is configured to control the vacuum pump, activate the vacuum pump to provide a set of random negative pressures within the chamber, calculate a one-repetition maximum (1RM) across the random negative pressures, and activate the vacuum pump to provide a target negative pressure within the chamber based on the 1RM.
Measure 1RM via random sequence of negative pressures
Measuring one-repetition maximum (1RM) of a subject by exposing the subject to a variety of negative pressures in a random sequence.
Provide negative airway pressure based on measured 1RM
Providing negative airway pressure to the subject based on the measured 1RM as treatment for obstructive sleep apnea.
In combination, the independent claims cover a system that generates random negative pressures in a sealed chamber, computes a 1RM from subject exposure, and then provides a target negative pressure based on that 1RM, and a method that treats obstructive sleep apnea using the same 1RM measurement concept followed by providing negative airway pressure based on the measured 1RM.
Stated Advantages
Tolerance increased in most cases, with no reported adverse events in the pilot described.
Apnea-hypopnea index (AHI) reduction was modest and not statistically significant in the pilot outcomes described.
Documented Applications
Treating obstructive sleep apnea using negative airway pressure provided based on a measured one-repetition maximum (1RM) with random negative pressure exposure.
A pilot protocol delivered over a multi-month timeframe, with reported outcomes including completion by 15 subjects and measurements including AHI and oxygen saturation nadir.
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