This paper presents the design, development and testing of a novel neck chamber device for non-invasive stimulation of an individual carotid baroreceptor in a graded manner. The proposed neck chamber device is a strap-free design that avoids discomfort during testing due to tight seal generated by the neck collar design, and facilitates unilateral testing and targeted assessment without stimulating other neck baroreceptors. The device consists of two independent components to achieve these requirements: an outer suction mechanism and an inner chamber. The outer mechanism consists of multiple suction cups to grip the device over the human neck, while the inner chamber creates controlled positive and negative pressure for stimulation of baroreceptors using a pump. The indigenously developed device was employed for the testing by providing neck chamber stimulation in discrete steps of –20 mm Hg, –40 mm Hg, −60 mm Hg, 0 mm Hg, 20 mm Hg, 40 mm Hg and 60 mm Hg with the gap of 60 s between each stimulation as per the standard test protocol of autonomic function test. The changes in heart rate and RR interval were recorded to determine the baroreceptor gain using the logistic equation derivative and gain curve plot. The results of the present study show that the estimated baroreceptor gain is –0.109±0.04, which is consistent with the previous studies conducted using neck collar devices. The testing results showed that the desired objectives are achieved successfully by the prototype device, opening up the possibility of its use for the treatment of resistant hypertension.
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Contributors All authors have made substantive intellectual contributions to the research work presented in the paper. PVP conceptualised the novel mechanism, under the supervision of KAD and PHK. PVP and KAD were lead researchers in terms of design, development and fabrication of the working prototype. PHK provided critical clinical inputs for approving the device design. PVP, PHK and AS made significant contributions to the survey tools, clinical trials, data collection and analysis. PHK, AS and RS managed the screening of participants and ensured the collection of clinical data according to protocol. KAD and PHK initiated the first draft of the manuscript, to which several iterations followed, with contributions from all authors. All authors approved the final version of the manuscript.
Funding The authors are thankful to the Department of Science and Technology for providing financial support (Project no: TDP/BDTD/09/2019) to carry out this research project.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The research protocol for the present work was approved by the Institutional Ethics Committee, All India Institute of Medical Sciences Jodhpur, India.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article.