Vagus Nerve Stimulation for Post-COVID Syndrome

Not Applicable

Completed

• Conditions: Heart Rates; Vagus Nerve Stimulations; Autonomic Nervous System Disorders; Long COVID
• Interventions: Device: Auricular transcutaneous vagus nerve stimulation

• Registration Number: NCT05679505
• Lead Sponsor: Bahçeşehir University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-04
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Left ear transcutaneous vagus nerve stimulation	Auricular 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.
Bilateral double ear transcutaneous vagus nerve stimulation	Auricular 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Iğdır State Hospital; 🇹🇷 Iğdır, Turkey