Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339632
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-25
Brief Title:
Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation
Sponsor:
Hospital Sirio-Libanes
Organization:
Hospital Sirio-Libanes
Study Overview
Official Title:
Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation a Randomized Controlled Crossover Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 generate action potentials and contractions of the muscle fibers of the diaphragm The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals Secondary objectives will be to assess the feasibility safety and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS
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 185 and 249 kgm2 without a history of previous respiratory diseases and without contraindications to undergo evaluation or application of the proposed electrical stimulation modalities will be included Participants diaphragm muscle will be assessed using ultrasound for variables such as thickness thickness fraction and diaphragm mobility Patients will be randomized using opaque envelope draw prior to evaluation into two distinct experimental moments 1 TEPNS moment - application of the TEPNS protocol or 2 TEDS moment - application of the TEDS protocol Additionally data regarding the feasibility and safety of the application of electrical stimulation modalities will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None