Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063166) titled 'Feasibility Study of Pulse Wave-Like Signal Measurement in Healthy Adults Using an Ultrasound Sensor System' on Oct. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tohoku university
Condition:
Condition - healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This exploratory study will assess noninvasive pulse waveform acquisition using an ultrasound sensor system under development in healthy adults. At the radial artery, two-site PWV will be assessed at rest, during leg elevation, and during deep breathing, and compared with changes in systolic blood pressure. At rest, waveforms from both common carotid arteries will be acquired and compared.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Several minutes of lower limb elevation/Several deep breaths
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Individuals aged 18 years or older at the time of enrollment
(2) Individuals who self-report that they have not been diagnosed by a physician with hypertension, cardiovascular disease, cerebrovascular disease, or respiratory disease that may affect their ability to perform deep breathing
(3) Individuals who are able to perform deep breathing and lower limb elevation without assistance
(4) Individuals who have provided written informed consent to participate in the study
Key exclusion criteria - (1) Individuals with a resting systolic blood pressure of 140 mmHg or higher or a resting diastolic blood pressure of 90 mmHg or higher before the start of measurement
(2) Individuals with wounds, inflammation, infection, or other skin conditions on the forearm or neck where the sensors and fixation devices will be placed
(3) Individuals with an allergy to polyurethane gel or a history of itching or redness associated with the use of ultrasound gel
(4) Individuals who are pregnant or who self-report the possibility of pregnancy
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 25 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072283
Disclaimer: Curated by HT Syndication.