VAGUS NERVE STIMULATION FOR POST COVID-19 SYNDROME

Study Overview
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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

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

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

Intervention / Treatment
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* Device: Auricular transcutaneous vagus nerve stimulation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left ear transcutaneous vagus nerve stimulation<br>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<br>* 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.<br>|
| Experimental: Bilateral double ear transcutaneous vagus nerve stimulation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale | 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). | 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). |