Oral use of an in-mouth wearable device in the treatment of dysphagia

A method for treating dysphagia comprising:

• fitting a patient afflicted with dysphagia with a TRP oral retainer-based device for wearing at night starting at about bedtime and during sleep, preferably for at least 8 hours;
• providing instructions to the patient to wear the device nightly for a period of time from about 2 to about 18 months or longer (the wearing period) as indicated based on strength of the patient's tongue;
• monitoring the patient's tongue pressure at one or more time points during the wearing period,
• wherein an increase in tongue strength compared to baseline, or compared to a prior monitoring time point during the wearing period, indicates that the patient receives a benefit from wearing the device or continues to receive a benefit from wearing the device and the patient's dysphagia is thereby treated;
• and
• wherein the TRP device is for limiting movement of a posterior or anterior zone of the tongue and stimulating the tongue, while allowing respectively an anterior or posterior zone and lateral edges of the tongue to perform movements necessary for speech and swallowing and comprises:
• an attachment mechanism adapted to releasably attach the TRP device teeth of the patient, the attachment mechanism comprising
• a first surface adapted to be positioned on a vestibular side of upper teeth of the dental arcade of the patient and
• a pair of second surfaces, comprising a left second surface and a right second surface, each second surface in opposition to the first surface and adapted to be seated along at least one and up to four posterior teeth of the wearer on the lingual side of the posterior teeth and
• a connector for joining a left end of the first surface with the left second surface and a connector for joining a right end of the first surface with the right second surface
• a tongue-constraining mechanism having
• a first and second end wherein each end of the constraining mechanism is optionally removably secured to a corresponding second surface of the attachment mechanism and
• a component transverse to and spanning between the first and second surfaces and having a forward or rearward orientation, the component being configured to sit at the occlusal plane of the patient or at an angle thereto the angle being within the range from +0 to −30 degrees lower than the occlusal plane and to limit movement of the corresponding zone of the tongue thereby confining the range of motion of the tongue to a more limited three-dimensional space within the mouth of the patient than in the absence of the device.