Tokyo, July 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062236) titled 'A study using non-contact millimeter-wave radar to continuously assess respiratory patterns in patients with cardiovascular diseases and patients newly starting CPAP therapy' on July 17.

Study Type: Observational

Primary Sponsor: Institute - Hirakata Kosei Hospital, Federation of National Public Service Personnel Mutual Aid Associations

Condition: Condition - Cardiovascular diseases and sleep apnea syndrome The cardiovascular conditions include angina pectoris or arrhythmia requiring elective percutaneous coronary intervention or catheter ablation, acute heart failure, and acute coronary syndrome. Patients with moderate-to-severe sleep apnea syndrome who are newly initiating continuous positive airway pressure therapy are also included. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Respiratory rate and respiratory patterns are important physiological parameters that reflect changes in the clinical condition of patients with cardiovascular diseases. However, continuous and objective assessment, especially during sleep, remains difficult in routine clinical practice.

Millimeter-wave radar (MWR) enables non-contact and unconstrained monitoring of respiratory activity by detecting subtle body surface movements without attaching sensors.

The primary objective of this prospective observational study is to evaluate the agreement between respiratory parameters measured using MWR, including respiratory rate, sleep apnea and hypopnea events, and periodic breathing, and those obtained using conventional monitoring methods in routine clinical practice. Study participants include patients undergoing elective percutaneous coronary intervention or catheter ablation, patients hospitalized for acute heart failure or acute coronary syndrome, and patients newly initiating continuous positive airway pressure (CPAP) therapy.

Secondary objectives are to investigate longitudinal changes in respiratory patterns before and after treatment, during the transition from the acute phase to the recovery phase, before and after cardiac rehabilitation, and their associations with clinical deterioration, treatment response, and recurrent cardiovascular events. In patients newly initiating CPAP therapy, the occurrence and longitudinal course of central sleep apnea, treatment-emergent central sleep apnea, and periodic breathing will also be explored.

No treatment modification, CPAP setting adjustment, or other research-specific intervention will be performed based on MWR measurements. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 18 years or older. 2. Patients scheduled to undergo elective percutaneous coronary intervention or catheter ablation for angina pectoris or cardiac arrhythmias. 3. Patients hospitalized for acute heart failure or acute coronary syndrome. 4. Patients scheduled to initiate CPAP therapy for sleep apnea syndrome. 5. Patients who provide written informed consent after receiving a full explanation of the study. Key exclusion criteria - 1. Pregnant women or women with possible pregnancy. 2. Patients who refuse study participation or MWR monitoring. 3. Patients considered unsuitable for study participation by the principal investigator. Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071188

Disclaimer: Curated by HT Syndication.