NCT07840144

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Sep 2028

First Submitted

Initial submission to the registry

September 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2028

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 15, 2026

Last Update Submit

September 21, 2026

Conditions

Physiological Stress

Keywords

Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (5)

  • Arterial Oxygen Saturation During Lower Body Negative Pressure

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

    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

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

    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

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

    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

    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.

    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

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

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

Study Arms (1)

Healthy Volunteers Undergoing Lower Body Negative Pressure

EXPERIMENTAL

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

Lower Body Negative Pressure with Noninvasive Physiological MonitoringDIAGNOSTIC_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.

Healthy Volunteers Undergoing Lower Body Negative Pressure

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

  • Michael J. Joyner, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Engrav

CONTACT

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

Ronee Harvey

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 24, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

September 28, 2028

Study Completion (Estimated)

September 28, 2028

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)