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NCT Number: NCT07840144

Lower Body Negative Pressure to Validate Physiological Monitors

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).

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Key information

Conditions

Physiological Stress

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower Body Negative Pressure with Noninvasive Physiological Monitoring

Diagnostic Test

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 outcomes

  1. 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

    Arterial oxygen saturation will be measured during lower body negative pressure using noninvasive physiological monitors

  2. 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

    ECG waveform will be measured during lower body negative pressure using noninvasive physiological monitor

  3. 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

    Respiratory rate will be measured during lower body negative pressure using noninvasive physiological monitors

  4. 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

    Plethysmography signals will be measured during lower body negative pressure from the pulse oximetry. Reported as a non-invasive research metric of central blood volume.

  5. 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

    Heart rate will be measured during lower body negative pressure using noninvasive physiological monitors

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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