Vagus Nerve Stimulation for Post-COVID Syndrome

Bahçeşehir University

Status: Completed

Conditions: Heart Rates; Autonomic Nervous System Disorders; Long COVID; Vagus Nerve Stimulations

Treatments: Device: Auricular transcutaneous vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05679505

STUDY003

Details and patient eligibility

About

The aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-VNS method in order to suppress the increased sympathetic activity in patients with prolonged Covid symptoms.The main question[s] it aims to answer are:

Question 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?

Question 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?

A 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being 18 years or older
• Experiencing at least one of the post-covid symptoms for 12 weeks or longer

Exclusion criteria

• Considering that the female reproductive hormones level in the body and menstrual cycle may affect the ANS in female patients, female participants in perimenopausal, post-menopausal and pregnancy conditions were excluded from the study.
• Participants who used medication for the treatment of ANS dysfunction in the last six months were also excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Left ear transcutaneous vagus nerve stimulation

Experimental group

Description:

Left ear transcutaneous vagus nerve stimulation will be applied to the participants in this group.A continuous electrical stimulation with a current frequency of 10 Heartz (Hz) with a current transit time of 300 μs was applied to the participants in both groups. The participants included in both groups were treated with taVNS with the "Vagustim" device for 20 minutes once a day and for a total of 10 sessions application was made.

Treatment:

Device: Auricular transcutaneous vagus nerve stimulation

Bilateral double ear transcutaneous vagus nerve stimulation

Experimental group

Description:

Bilateral double ear transcutaneous vagus nerve stimulation will be applied to the participants in this group.A continuous electrical stimulation with a current frequency of 10 Heartz (Hz) with a current transit time of 300 μs was applied to the participants in both groups. The participants included in both groups were treated with taVNS with the "Vagustim" device for 20 minutes once a day and for a total of 10 sessions application was made.

Treatment:

Device: Auricular transcutaneous vagus nerve stimulation