Trial intervention of an oral device for the management of oral care and swallowing in an aged care population

The study aims to test procedures for acceptability and feasibility of a myofunctional device (MyoMunchee) in improving oral health and dysphagia in residents 65> years old in an aged care setting over a five week intervention period. The Myofunctional Device (MyoMunchee ) has been approved by the Australian Government Department of Health (2019), Therapeutic Goods Administration as a medical device class 1 (low risk device), with intended purpose to exercise the jaw and surrounding muscles, as well as other conditions treated by oral motor therapy. The myofunctional device (MyoMunchee ) is ISO 13485 certified by the Standard for Quality Management System for design and manufacturing of medical devices, and is made of non-toxic medical grade silicone. This will be a single intervention site study, conducted at an aged care facility in Newcastle, Australia, with data analysis occurring at the University of Newcastle, Australia. Pre and post treatment outcome measures will be taken for comparison, and will be completed by the PhD student investigator who is qualified clinical speech pathologist (with over 17 years clinical experience) with reliability checking of 10% of residents onsite at the aged care facility by another qualified clinical speech pathologist from the University of Newcastle. Before the intervention commences the student investigator will provide training to care staff (including nursing staff and allied health/speech pathology staff) on the device use, cleaning procedures for the device, and the intervention protocol. Four training sessions will be available to staff. Each training session will be delivered face to face at the facility. The training session will be 60 minutes in duration and include practical demonstration of device use and cleaning. The training will also review guidelines and safe use of the device including monitoring of increased saliva production and clinical signs of aspiration, as well as data collection procedures. Adherence to training will be monitored by the researcher weekly and will involve the collection of data sheets and informal discussions with care staff. Care staff will provide one on one supervision/assistance to the aged care residents across the five week trial intervention with the device. The myofunctional device (MyoMunchee ) will be used by the aged care resident twice daily (morning and evening recommended at the time of usual oral care routine) by the participants. The use of the MyoMunchee involves the participant to place the device inside their mouth (similar to a mouth guard) and chew gently (similar to chewing gum or meat) for the specified time period as per the protocol. The duration for device use will start at 1 minute twice a day in the first week, and increase to 2 minutes twice a day in the second week, 3 minutes twice a day in the third week, 4 minutes twice a day in the fourth week, and 5 minutes twice a day use in the fifth week of intervention. Adherence to treatment will be measure by way of daily checklist completion by the care staff, which will be collected at the end of each week and stored by the research team for the duration of the trial. Further to this a survey of the residents completing the intervention, as well as a questionnaire for the care staff assisting participants with the intervention will be taken at the completion of the five week intervention trial.