Myofunctional Device Use in Oral Care and Swallowing: Protocol for a Pilot Study in an Aged Care Population

Poor oral health is a known predictor of aspiration pneumonia in vulnerable populations such as the elderly and chronically ill and has been linked to systemic disease, morbidity, and mortality. Reduced oral health not only places individuals at a greater risk of aspiration pneumonia but may result in pain or poorer dentition which can impact on mastication and swallowing. Consequences of this may include reduced oral intake, malnutrition, poorer health outcomes and reduced quality of life. Few evidence-based protocols exist to manage oral care in aged care populations, and maintenance of good oral hygiene is dicult for nursing and care staff to facilitate. However, myofunctional devices reportedly improve oral hygiene, oral behaviours, and swallowing, along with breathing and speech. The primary aims of this study are to assess the feasibility and acceptability of a using a myofunctional device to improve oral care and swallowing function in an aged care population. This project is a pilot study that involves a ve-week intervention for oral hygiene and dysphagia for residents >65 years old in an aged care setting. Feasibility will be measured by number of consenting participants, trial completion rates, and treatment adherence. Acceptability will be measured through verbal surveys of aged care residents and a questionnaire of care staff assisting with the intervention. Secondary outcome measures will record changes in oral hygiene and dysphagia pre and post intervention. The results of this trial will provide important information regarding the acceptability and feasibility of utilising a myofunctional device to improve oral care and dysphagia in elderly patients in an aged care facility. This knowledge will further guide and inform design of a larger trial or future research.

Currently there are limited oral care protocols with measurable outcomes that are used in hospitals and care facilities in Australia [14]. These protocols have been described as ad-hoc and often not prioritised in patient care [14]. This is of concern to speech pathologists due to the impact of poor oral health on mastication, swallowing function and increased risk of aspiration. However, a recent literature review [15] found that improvements in oral hygiene, oral behaviours, and swallowing, along with breathing and speech have been found to be associated with the use of orofacial myofunctional therapy and myofunctional devices [16].
In a study by Shortland and colleagues (manuscript in preparation) into speech pathologists' use and outcomes of myofunctional devices in therapy programs, there was found to be both similarities and differences in the use of myofunctional devices, and the therapy programs in which these devices are incorporated. This varied across intervention areas, caseloads and diagnoses amongst speech pathologists who utilized them. Shortland and Colleagues (manuscript in preparation) noted that the type of myofunctional device, timing of introduction, utilisation in isolation, adherence, and dosage variation of myofunctional devices used contributed to successful outcomes for swallowing, oral hygiene, breathing and speech. However, further education and research into myofunctional device use and guidelines to direct their use in speech pathology intervention was recommended, along with a coordinated approach and team input in assessment and intervention.
Despite this increase of evidence, there is limited research in speech pathology that addresses the use and outcomes of myofunctional devices in clinical practice [15]. The potential impact of improvement on orofacial function, including oral hygiene and swallowing, has already been identi ed with the use of myofunctional devices in literature from various health disciplines [17]. As well as this, there is a link between reduced oral hygiene and aspiration pneumonia [18], and the impact of a reduction in oral hygiene on quality of life [19]. It is relevant to further explore treatment dosage, utilisation, and outcomes of a myofunctional device in a population such as the elderly who make up a large proportion of those whose oral health and swallowing function may be impacted on [20].
This pilot study will provide necessary information to undertake a randomised control trial. The current research protocol will allow analysis of feasibility by testing procedures of myofunctional device use for acceptability, recruitment, and retention of participants. It will also determine sample size required for a larger clinical trial to evaluate the use and outcomes of a myofunctional device in oral care and dysphagia treatment in an adult population in care facilities.

Design Overview
This is a single-arm pilot study designed to examine the feasibility and acceptability of the use of a myofunctional device in improving in oral health and dysphagia in a residential, aged care population. The protocol presented is based on both the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [21] and Consolidated Standards of Reporting Trials (CONSORT) [22] guidelines, to conduct an acceptability and feasibility pilot study. The proposed protocol is for a 5-week intervention period that involves twice daily use of a myofunctional device called MyoMunchee Badge Copyright outline. There have been no previous trials using the MyoMunchee Badge Copyright outline for management of oral hygiene and dysphagia with residents of an aged care setting. However, the intervention protocol was based on previous research, a cluster randomised control trial utilised a myofunctional device to promote lip closure and nasal breathing for oral neuromuscular training for those 65 years and older in short term care units with impaired swallowing [17]. The results indicated that swallowing function signi cantly improved for those in the intervention group immediately following 5 weeks of therapy and a signi cant reduction in signs of aspiration 6 months post treatment was found compared to the control group.
If this trial is found to be acceptable and feasible, the results will provide information for calculating the sample size needed for a randomised control trial [23,24]. An overview of the study procedures is provided in Figure 1.

Primary Aims
The primary aims of this pilot study are to determine the acceptability of the device and intervention, feasibility of recruitment and adherence to intervention, and the preliminary effect of the device and intervention on oral hygiene and swallowing function. Aim 1. The acceptability of the new treatment intervention will be determined by treatment adherence, participant experience using the device and resident satisfaction with the treatment intervention.
Aim 2. The feasibility of the treatment intervention will be determined by consenting rates, intervention completion rates, and intervention adherence.
Aim 3. Determine the extent to which the device and treatment improve oral health, the reduction of perceived dysphagia symptoms and presence of dysphagia.

Study Setting and Recruitment
This will be a single intervention site study, conducted at an aged care facility (ACF) in Newcastle, Australia, with data analysis occurring at the University of Newcastle, Australia. The ACF consists of residents ranging in level of care including self-assisted retirement village living, residential care, low to high need dementia care and palliative care.
Participants will be recruited with the assistance of care staff (nursing/allied health professionals) at the ACF, by the provision of recruitment yers and participant information statements outlining the study to residents/legal guardians who meet the inclusion criteria.
All residents and care staff who meet the selection criteria will be eligible to participate in this study. They will be identi ed by the Nursing Unit Managers (NUM) and the speech pathologist/s at the ACF and provided with an information yer. The contact details for the study team have been provided on all yers and information statements inviting prospective participants/legal guardians to contact the study team prior to enrolment in the study.
Care staff will be assisting in providing the intervention as part of their routine care for residents but will be invited to participate in a post intervention questionnaire through study yers placed in break rooms and following intervention education sessions by the study team. All care staff will be supervising and assisting with the intervention for residents who consent to the research, as part of their usual oral care routine. This is approved and directed by management at trial site as part of their employee role. Care staff will be invited to participate a post intervention questionnaire regarding their experience of supervising and assisting residents with the trial intervention. Care staff who wish to participate in the post intervention questionnaire will need to complete a consent form and questionnaire which will be provided by the Nursing Unit Manager (NUM) of their ward.
The residents/families of residents/care staff will be provided with a participant information statement regarding the study, and then followed up by the NUM/speech pathologist for interest in study participation. There will be an opportunity for residents, family of residents, and care staff to ask questions before and after consenting to participate. Questions regarding the study can be directed by the staff at the ACF to the Principal Investigator.
Residents/family of residents/care staff will be required to sign and provide written consent for participation. Time for consideration and return of consent for participation in the study will be 7 days after initial contact.
Explanation will be provided to residents/family of residents that their usual oral health care and dysphagia treatment will not vary with or without participation in this study. Further to this, a statement will be provided to participants that based on the results of the pilot study, a larger clinical trial using the intervention may not be performed.
This research will involve the use of information without personal identi ers, and it will be obtained from individuals or gathered from medical les by care staff appointed by the ACF.
As this is a feasibility pilot study utilising a myofunctional device not previously trialled in this setting, all consenting residents will receive the treatment intervention to better understand acceptability of the device and feasibility of completing a larger trial. No randomisation of participants will occur. The aim is to recruit 50 residents and 10 staff as participants in this research. This is based on the available recruitment pool, and the number of residents who may not give consent. Because this is a feasibility study this does not require a sample size base.
The expected period to recruit participants is four weeks.

Participants
Participants will include a sample of 50 residents from the ACF and 10 care staff (nursing and/or allied health staff) who will oversee the daily use of the device during the treatment period.
Residents at the ACF who meet the following selection criteria and who consent to participating in the study will receive the treatment.
1. age > 65 years 2. Ability to understand English and follow instructions for timed water swallow test and use of the myofunctional device 3. Residents receiving texture modi ed diets (including normal cut up, easy chew, minced moist, and puree diets) and/or uids 4. Residents with natural teeth, dentures (partial and full), and edentulous Residents will be excluded for the following reasons: Care staff will be included if they are care staff approved by the ACF to participate in monitoring the intervention as part of their usual duties. Care staff will be excluded if they are not nursing or allied health professionals.

Study Intervention
Aged care resident participants will complete a 5-week intervention program using the MyoMunchee Badge Copyright outline. The device will be used twice daily (morning and evening recommended at the time of usual oral care routine) by the participants. This will require active use of the device with the action of chewing following the placement of the device in the oral cavity. The duration for device use will start at 1 minute twice a day in the rst week, and increase by one minute each week, to 5 minutes twice a day by the fth week of intervention (as seen in Table 1).
Care staff will facilitate the delivery of the 5-week intervention, 7 days per week, with daily monitoring and twice daily documentation of the use of the device. The research team will provide the residents/care staff with instructions and a guide for the use of the device with education regarding familiarization and instructions for use of the device (MyoMunchee ), cleaning and storage of the device, and documentation of device use. Explanation regarding the cleaning, cleaning schedule and storage of this will be provided as per MyoMunchee cleaning protocol, which includes rinsing the device in water before and after use, shaking dry and storing in the provided storage container. Supervision with device use and documentation of completion of intervention twice daily. This will continue from weeks 1-5.
Week 2 Device use twice daily for 2 minutes (morning and evening) Week 3 Device use twice daily for 3 minutes (morning and evening) Week 4 Device use twice daily for 4 minutes (morning and evening) Week 5 Device use twice daily for 5 minutes (morning and evening)

Treatment Fidelity
Twice daily use of the myofunctional device will be recorded by the care staff at the ACF via a checklist. An example of the rst week of intervention checklist is provided in the appendix (Appendix A.). The NUMs for each area of the ACF will ensure care staff are accurately documenting intervention completion. The daily checklist will be collected by the care staff at the ACF at the end of each week of intervention and replaced with a new checklist for the corresponding week of intervention which includes instructions on the duration of device use for that week. The study team will be available to answer questions from the care staff regarding the intervention during the ve weeks and monitor for deviations from the study protocol such as the use of the device or adherence of the participant or the study site staff.

Participant Retention
Strategies used to maximise participant retention include education and training provided to care staff who will be responsible for facilitating the delivery of the intervention, ensuring the intervention is completed twice daily for the speci ed duration. Participants will be provided with the device for the duration of the intervention and will also be permitted to retain the device following the intervention period.

Safety Monitoring
This study involves a new intervention with a vulnerable population. However, the intervention uses a device that has Australian Therapeutic Goods Approval and the residents who will be using this device will be monitored by care staff during the intervention as per Table 2. below. If coughing occurs through use of the device and increased saliva production, a referral will be made for review by the medical o cer, as well as speech pathology at the ACF to review swallowing function (and appropriateness for continuation in the study) Initial discomfort to gums/jaw with the action of chewing the device The treatment intervention incorporates staged in time use of the device, increasing weekly to allow for adjustment to oral comfort. Supervision by care staff will be provided during the device use. If oral discomfort is identi ed/reported, a review by the researcher and speech pathologist at the ACF will take place and recommendations will be made regarding continuation in the study.
Sizing and selection of the device has been considered for oral comfort and ease, placing, and removing the device from the oral cavity with an eternal tab/handle.
Infection control Staff will be trained in cleaning protocols for the device to reduce the risk of infection. This will be tracked with the completion of a daily check list by care staff at the ACF.
The risks to the participants' undertaking intervention are considered negligible to low risk. There is low foreseeable risk of harm or discomfort [25]. There are no known risks for the care staff assisting with the intervention outside of usual oral care assistance.
Further considerations have been made regarding storage and labelling of the devices to minimise infection control risks (as per Table 3.) Table 3 Device considerations and storage

Potential Concern Strategy
Device labelling/identi cation Devices will be stored as per dentures in storage container speci cally for the MyoMunchee, labelled with the participant's identi cation number.
The MyoMunchee will be stored as per the ACF protocol for storage and identi cation of usual oral hygiene products Lost/misplaced device In the event of the MyoMunchee being misplaced/lost a new replacement device will be provided Data monitoring will occur throughout the study for the safety of residents undergoing the intervention via review of pre and post intervention assessment results, daily monitoring by care staff and review of daily data sheets to prevent adverse events.
Monitoring and reporting of adverse events (AE), serious adverse events (SAE) and unexpected events (UE) will be conducted as per the ACF incident reporting system 'ionMY' (governance, risk management, compliance platform), and entered by care staff as per the ACF incident reporting guidelines. Discontinuation of intervention for a participant may occur if an AE or medical condition occurs such that participation in the study would not be in the best interest of the participant or the participant met an exclusion criterion (newly developed or not identi ed on consent) that precludes further study participation.

Assessments and Measures
Acceptability of the intervention will be measured by administering a resident acceptability survey to all enrolled residents, regarding the participant experience of ease of use, comfort with use, and if there were perceived changes to oral health or swallowing following the use of the device. The survey of the residents receiving the intervention regarding experience using the device, will use a 5-point Likert scale (very di cult -very easy), and dichotomous questions (yes -no). Assistance in reading the survey for residents with visual impairment, aphasia, and cognitive and intellectual impairment will be provided by a staff member at the ACF. Acceptability will be further measured through the administration of a care staff acceptability questionnaire to those assisting with the intervention, as well as perceived acceptance of the device by residents.
Feasibility of intervention will be measured by the number of potential participants versus consented, intervention completion rates, and adherence to the intervention (monitored by care staff through supervision of the intervention, and completion of daily intervention sheets). Feasibility will be further measured on the care staff questionnaire to rate the ease of use and cleaning of the device, and the impact on workload. This questionnaire will use both a 5-point Likert scale (very di cult -very easy), dichotomous questions (yes -no), and free text.
Outcome measures to provide preliminary data on the effect of the treatment on oral care and swallowing function will be collected 1-week pre and post intervention. Exploratory measures include oral health, aspiration risk, mastication ability, presence of dysphagia, functional oral intake, self-perception of eating, and cognitive function. Details of each of these measures are provided in Table 4.  The number residents approached to participate in the study versus those who consented to participate will be collected in the recruitment period before pre intervention assessments commence (as per Table 4). The intervention completion rate of those who consented to participate and those who completed the ve-week intervention will be collected following the ve-week intervention and collection of post intervention assessment. Data will be collected for adherence to the intervention during the ve-week study period by way of daily checklist completion by the care staff that residents have completed the intervention twice daily for the speci ed amount of time. The checklist will be collected at the end of each week and entered in an electronic database each week by the principal investigator. 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 ve-week intervention trial.
Pre and post intervention outcome measures collected for comparison to observe changes in oral hygiene and swallowing function. Data collection of outcome measures will be completed by a quali ed clinical speech pathologist/principal investigator (with over 17 years clinical experience). Reliability checking of pre and post outcome measure collection of 10% of residents will occur onsite at the ACF by a quali ed clinical speech pathologist from the University of Newcastle, independent of the study.
Resident participant's demographic data (see Figure 2.) will be extracted from the medical les of each consenting participant by an employee appointed by the ACF. The data will be deidenti ed using a code and then provided to the research team.

Data Analysis
A sample size calculation is not appropriate for this study as it is a Stage 1 Pilot study. However, our target sample size is 50 residents and 10 care staff which is based on the available recruitment pool. Assessment of consenting rates versus intervention completion rates will involve statistical analyses and will be performed using SPSS, version 22. The primary outcome will be reported as numbers and percentages. Outcome measures will be summarised using mean (SD) for normally distributed data, median (interquartile range) for non-normally distributed data and number (percent for categorical data). Pre and post-intervention comparisons will be performed using a paired t-test. Effect size and 95% con dence interval will be calculated. The signi cance level will be set at p<0.05. In addition, for each of the secondary outcome measures, linear regression will be used to measure changes in secondary variables while controlling for age, cognition, adherence, comorbidities, and ability to implement the MyoMunchee independently.
Data collected through post intervention survey of residents and care staff questionnaires will use qualitative content analysis as described by Graneheim and Lundman [33] to analyse participants' free text responses. Free text data will be transcribed verbatim and analysed with NVivo 12.0 Software to assist with the identi cation of patterns in the text segments of the care staff questionnaire. For questions using a Likert scale data will be analysed descriptively using distribution of responses provided by participants.

Discussion
The link between oral health and the inability to manage this independently is a known predictor of aspiration pneumonia in vulnerable populations such as the elderly and chronically ill [18]. The links between poor oral health with systemic disease, morbidity and mortality has been demonstrated extensively throughout allied health, nursing, and dental literature [5]. If oral health is reduced, people are not only at greater risk of aspiration pneumonia, but they may have pain or poorer dentition which impacts on mastication and swallowing, and reduced oral intake, with potential for malnutrition, poorer health outcomes and reduced quality of life [19].
The results of Shortland and colleagues [15] systematic review reported improvements in oral hygiene, oral behaviours, and swallowing, along with breathing and speech to be associated with the use of myofunctional devices. Therefore, it would be relevant to further explore treatment dosage, utilisation, and outcomes of a myofunctional device in a population such as the elderly who make up a large proportion of those whose oral health and swallowing function may be impacted [20].
The outcomes from this study of acceptability and feasibility of test procedures for the use of a myofunctional device in improving in oral health and dysphagia in an aged care population, will further guide the design of a randomized control trial.

Consent for publication
All participants/guardians are required to provide signed consent to participate in this study and agree to the publication of unidenti able group data.

Availability of data and materials
The study will adhere to The Australian Code for the Responsible Conduct of Research (2018) as well as the University of Newcastle Data management policy (2017).
Following the publication of the pilot study the datasets used and analysed will be available from the author on reasonable request.

Competing Interests
A scholarship between the University of Newcastle and an industry partner MyoMunchee has been provided to the rst author completing a higher degree of research. The authors alone are responsible for the recruitment of participants, collection and analysis of data, and the content and writing of the paper.

Funding
A scholarship between the University of Newcastle and an industry partner MyoMunchee has been provided to the rst author completing a higher degree of research. The authors alone are responsible for the recruitment of participants, collection and analysis of data, and the content and writing of the paper.
Author's contributions HS, SH, and GW planned the project, developed the research design. SH, GW and AV were responsible for supervising HS (higher degree research student) in the design of this protocol. HS wrote the rst draft of the manuscript, and SH and GW were responsible for revisions. All authors revised the nal manuscript for submission.

Figure 1
Flowchart of study procedures Resident data collection form

Supplementary Files
This is a list of supplementary les associated with this preprint. Click to download. AppendixA.Protocol.docx