Status:

RECRUITING

Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation

Lead Sponsor:

Hospital Sirio-Libanes

Collaborating Sponsors:

Hospital Israelita Albert Einstein

Conditions:

Diaphragm

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to genera...

Detailed Description

This crossover trial, single-blind, bicentric study will be conducted at two hospitals. Adult volunteers aged 18 to 60 years, healthy, with a body mass index between 18.5 and 24.9 kg/m2, without a his...

Eligibility Criteria

Inclusion Criteria:

  • Age between 18 and 60 years;
  • Normal pulmonary function test, without alterations, assessed through spirometry;
  • Body Mass Index (BMI) between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

  • Smokers or former smokers;
  • Individuals with previously known cardiopulmonary diseases (restrictive lung diseases, chronic obstructive pulmonary disease - COPD, asthma, cystic fibrosis, among other pathologies);
  • Presence of implanted electrical devices (pacemaker, implantable cardioverter-defibrillator, among others);
  • Individuals who have contraindications to undergo evaluation and/or application of transcutaneous electrical stimulation of the diaphragm muscle, such as: altered sensitivity, wounds at the site of application, deformities, among other conditions.

Key Trial Info

Start Date :

April 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT06339632

Start Date

April 1 2024

End Date

March 1 2026

Last Update

April 24 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hospital Sírio Libanês

São Paulo, São Paulo, Brazil, 01308-050