Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07840144

Conditions

Physiological Stress

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Lower Body Negative Pressure with Noninvasive Physiological Monitoring

Study Details

Brief summary:

The purpose of this research is to test the accuracy of non-invasive physiological monitors while the body responds to different levels of lower body negative pressure (LBNP).

Conditions

Physiological Stress

Study ID

NCT07840144

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Sep 28, 2028

Anticipated

Primary completion date

Sep 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Non-obese (BMI<30)
  • Non-smokers
  • Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity.
  • Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test (within 48 hours of the study day)

Exclusion Criteria:

  • Individuals taking GLP-1 medications or compounds known to affect responses of the autonomic nervous system to orthostatic stress (e.g., β-blockers)
  • Pregnant women

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers Undergoing Lower Body Negative Pressure

Healthy adult participants will complete one study visit involving graded lower body negative pressure while standard physiological reference measurements and noninvasive investigational physiological monitor data are collected.

Interventions

Lower Body Negative Pressure with Noninvasive Physiological Monitoring

Participants will undergo a graded lower body negative pressure protocol using suction levels of 15, 30, 45, 60, 70, 80, 90, and 100 mmHg, each for up to 5 minutes or until presyncopal symptoms or other termination criteria occur. During the procedure, validated reference physiological measurements and investigational noninvasive monitor signals will be collected simultaneously.

Primary outcome measure

  • Arterial Oxygen Saturation During Lower Body Negative Pressure [ Time Frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes ]
  • ECG Waveform During Lower Body Negative Pressure [ Time Frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes ]
  • Respiratory Rate During Lower Body Negative Pressure [ Time Frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes ]
  • Plethysmography Signals During Lower Body Negative Pressure via physiological monitors [ Time Frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes ]
  • Heart rate During Lower Body Negative Pressure [ Time Frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes ]

Central Contacts and Locations

Central contacts

Pamela Engrav

507-255-6938engrav.pamela@mayo.edu

Ronee Harvey

507-255-1466harvey.ronee@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Pamela Engrav

507-255-6938

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Hemodynamic Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.