Quantification and Repeatability of Responses to Rapid Bilateral Magnetic Stimulation of the Phrenic Nerves

Swiss Federal Institute of Technology1 site in 1 country16 target enrollmentJuly 13, 2022

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Swiss Federal Institute of Technology
Enrollment: 16
Locations: 1
Primary Endpoint: Diaphragm contractility
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this project the quantification and the repeatability of responses to rapid bilateral magnetic stimulation of the phrenic nerves will be investigated in healthy humans.

Registry

clinicaltrials.gov

Start Date

July 13, 2022

End Date

December 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Swiss Federal Institute of Technology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•non-smoking
•normal lung function
•body mass index: 18.5-29.9 kg/m2
•able to communicate in english
•willing to adhere to study rules

Exclusion Criteria

•acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
•intake of medications affecting metabolism, the cardiovascular, the neuromuscular or the respiratory system, or sleep
•any metal or electronics inside of the body
•presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators
•history of seizures or epilepsy
•tatoos on the stimulation sites
•previous enrolment in this study
•for women: pregnancy, breastfeeding, or intention to become pregnant during the study

Outcomes

Primary Outcomes

Diaphragm contractility

Time Frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec

Transdiaphragmatic pressure changes, i.e. changes in esophageal and gastric pressures, will be measured by a pressure transducer connected to balloon-catheters.