Vagus Nerve Stimulation for Post-COVID Syndrome

NCT ID: NCT05679505

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2023-01-04

Brief Summary

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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

Detailed Description

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Conditions

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Long COVID Vagus Nerve Stimulations Heart Rates Autonomic Nervous System Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Left ear transcutaneous vagus nerve stimulation

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.

Group Type EXPERIMENTAL

Auricular transcutaneous vagus nerve stimulation

Intervention Type DEVICE

Transcutaneous vagus nerve stimulation (taVNS) was performed with an FDA-approved Vagustim stimulation device and an electrode-shaped earpiece. In the participants included in the study and randomized to two groups, i) left ear taVNS was applied to the first group and ii) double-ear taVNS was applied to the second group.

Bilateral double ear transcutaneous vagus nerve stimulation

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.

Group Type EXPERIMENTAL

Auricular transcutaneous vagus nerve stimulation

Intervention Type DEVICE

Transcutaneous vagus nerve stimulation (taVNS) was performed with an FDA-approved Vagustim stimulation device and an electrode-shaped earpiece. In the participants included in the study and randomized to two groups, i) left ear taVNS was applied to the first group and ii) double-ear taVNS was applied to the second group.

Interventions

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Auricular transcutaneous vagus nerve stimulation

Transcutaneous vagus nerve stimulation (taVNS) was performed with an FDA-approved Vagustim stimulation device and an electrode-shaped earpiece. In the participants included in the study and randomized to two groups, i) left ear taVNS was applied to the first group and ii) double-ear taVNS was applied to the second group.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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Alper Percin

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramazan Erenler, Prof. Dr.

Role: STUDY_CHAIR

Igdir University

Locations

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Iğdır State Hospital

Iğdır, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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STUDY003

Identifier Type: -

Identifier Source: org_study_id

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