VAGUS NERVE STIMULATION FOR POST COVID-19 SYNDROME

Sponsor

Bahçeşehir University (Other)

Overall Status

Completed

CT.gov ID

NCT05679505

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Long COVID Vagus Nerve Stimulations Heart Rates Autonomic Nervous System Disorders	Device: Auricular transcutaneous vagus nerve stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

EFFECTS OF VAGUS NERVE STIMULATION IN POST COVID-19 SYNDROME: A RANDOMIZED CONTROLLED TRIAL

Actual Study Start Date :

Oct 27, 2022

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Jan 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Device: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Experimental: 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.

Device: Auricular transcutaneous vagus nerve stimulation

Outcome Measures

Primary Outcome Measures

Heart Rate Variability [After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later).]
HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time. It analyzes the change in the beat-beat intervals of the heart and reflects the balance between PNS and SNS. During the analysis of heart rate variability measurement, the results obtained from sub-parameters such as stress index, time-domain and frequency-domain measurements allow evaluation of PNS and SNS activity.

Secondary Outcome Measures

Fatigue Severity Scale [After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later).]
The Fatigue Severity Scale, which is applied in the form of a questionnaire to determine the severity of fatigue accompanied by chronic diseases, consists of a total of 9 questions and according to the results obtained, it gives results as No Fatigue (<2.8 points) and chronic fatigue syndrome (>6.1 points).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iğdır State Hospital	Iğdır		Turkey	76000

Sponsors and Collaborators

Bahçeşehir University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alper Percin, Lecturer, Bahçeşehir University

ClinicalTrials.gov Identifier:

NCT05679505

Other Study ID Numbers:

STUDY003

First Posted:

Jan 11, 2023

Last Update Posted:

Jan 11, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Nervous System Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Study Results

No Results Posted as of Jan 11, 2023