Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060311) titled 'Investigation of the Effects of Stochastic Resonance on Oral and Swallowing Function' on April 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Others

Condition: Condition - Dysphagia, Oral-hypofunction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to conduct a pre-post interventional clinical study involving older adults with reduced swallowing function and patients with dysphagia. Specifically, we will evaluate changes in the cough reflex threshold, swallowing reflex latency and initiation site, tongue pressure, masticatory performance, two-point discrimination of the tongue, tongue roughness discrimination ability, and tongue tactile sensation, in order to investigate the effects of stochastic resonance noise vibration stimulation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The cough reflex threshold, swallowing reflex latency and initiation site, tongue pressure, masticatory performance, two-point discrimination of the tongue, tongue roughness discrimination ability, monofilament test results, and tongue tactile function were measured at three time points: before the intervention (Pre), during the intervention (Mid), and after the intervention (Post), in order to evaluate immediate changes and short-term residual effects.

To prevent the measurement results of each parameter from being influenced by other assessments, the three-stage measurements (Pre, Mid, and Post) for each parameter were performed consecutively, followed by the measurements of the next parameter. This measurement sequence minimizes interference among different assessment items and enables a more accurate evaluation of the immediate and short-term effects of stochastic resonance stimulation.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants must be able to understand the study procedures, voluntarily agree to participate, and provide written informed consent.

Participants must have intact cognitive function, defined as a Clinical Dementia Rating (CDR) score of 0, and be able to sufficiently understand the experimental instructions and perform the assessments of oral, tongue, and masticatory functions as instructed.

Participants must have oral and tongue functions that allow participation in the vibration stimulation experiment, including basic sensory and motor abilities of the tongue. Key exclusion criteria - Individuals with cognitive or psychiatric impairments, including severe cognitive impairment, severe psychiatric disorders, or alcohol or drug dependence, who are unable to understand the experimental instructions or complete the measurements.

Individuals taking medications that may affect oral sensation or tongue muscle function, such as sedatives, anesthetics, or muscle relaxants.

Any other individuals deemed unsuitable for participation by the principal investigator, including those with markedly poor general health or a limited life expectancy. Target Size - 38

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 18 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068991

Disclaimer: Curated by HT Syndication.