Funding for this research was provided by:
Enterprise Ireland (CF/2013/3614)
University of Limerick
Article History
Received: 13 August 2021
Accepted: 11 January 2022
First Online: 4 February 2022
Declarations
:
: The authors have no relevant financial or non-financial interests to disclose.
: Ethics approval for this study, which conformed to the Helsinki Declaration, was obtained from the University of Limerick, Faculty of Education and Health Sciences research ethics committee. Approval to use a novel medical device, OroPress, in this clinical investigation was approved by the designated authority for Ireland, the Health Products Regulatory Authority (HPRA) with reference numbers CI0053#0 - CRN 2148129 EUDAMED Reference Number: CIV-IE-14-06-012200, 15 Dec 2015.
: Participants were recruited by use of advertising posters and verbal requests. A total of 35 normal healthy adults were purposefully recruited (17 males and 18 females). Participants were screened by use of a short questionnaire about their past and present swallowing function. Exclusion criteria included having a history of a swallowing and/or speech disorder; having a medical condition, or use of medications, that may affect swallowing. An oro-motor examination excluded people with any oral abnormality and those with an overly sensitive gag reflex (i.e., gag reflex triggered in the middle portion of the anterior tongue). Persons unable to give informed consent or to follow oral instructions were also excluded. Informed consent was obtained from all individual participants included in the study.
: Informed consent was obtained from all individual participants included in this clinical investigation.