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RecruitingNCT07840144Updated Sep 24, 2026

Lower Body Negative Pressure to Validate Physiological Monitors

An interventional study of Lower Body Negative Pressure with Noninvasive Physiological Monitoring in Physiological Stress, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Physiological Stress

Keywords

  • Hemodynamic Monitoring
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study 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.

    Diagnostic Test: Lower Body Negative Pressure with Noninvasive Physiological Monitoring

Interventions

  • Diagnostic testLower 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.

05

What researchers measure

Primary outcomes

  1. Arterial Oxygen Saturation During Lower Body Negative Pressure

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

    Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes

  2. ECG Waveform During Lower Body Negative Pressure

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

    Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes

  3. Respiratory Rate During Lower Body Negative Pressure

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

    Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes

  4. Plethysmography Signals During Lower Body Negative Pressure via physiological monitors

    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.

    Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes

  5. Heart rate During Lower Body Negative Pressure

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

    Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes

06

Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    • Pamela Engrav · Contact · 507-255-6938
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07840144
Lead sponsor
Mayo Clinic
Responsible party
Michael J. Joyner, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 24, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 28, 2028 (estimated)
Completion
Sep 28, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Pamela Engrav
Contact
engrav.pamela@mayo.edu
507-255-6938
Ronee Harvey
Contact
harvey.ronee@mayo.edu
507-255-1466
Michael J. Joyner, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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