Safety evaluation of a lower-limbs artificial negative pressure device in healthy subjects: single-group trial

JRCT ID: jRCTs052240069

Registered date:20/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 20/06/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Five tests will be conducted on the study participants: a sitting test, a standing test, a low-intensity lower-limbs artificial negative pressure (LANP) test, a moderate-intensity LANP test, and a high-intensity LANP test.

Outcome(s)

Primary Outcome

Presence or absence of adverse events
Presence or absence of malfunctions in the test equipment

• Secondary Outcome: Changes in cardiovascular parameters from rest during LANP loading and gravitational loading

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

1) Individuals who have provided consent.
2) Healthy subjects aged 18 years or older but less than 40 years at the time of obtaining consent.
3) Individuals with normal resting blood pressure (systolic blood pressure 100 to 139 mmHg and diastolic blood pressure 60 to 89 mmHg).
4) Normal weight individuals (BMI 18.5 to 24.9).

Exclude criteria

1) Individuals who have experienced orthostatic hypotension accompanied by symptoms such as dizziness or nausea in the past 6 months.
2) Individuals with tachyarrhythmic or bradyarrhythmic arrhythmias.
3) Individuals taking cardiovascular medications that affect blood pressure, heart rate, or autonomic nervous activity (antihypertensive drugs, antiarrhythmic drugs, heart failure treatment drugs, etc.).
4) Women who are pregnant, may be pregnant, or are breastfeeding.
5) Others deemed inappropriate for the study by the investigator.

Related Information

• Primary Sponsor: Sakai Yoshitada