Effects of Vagus Nerve Stimulation in Post-COVID-19 Syndrome: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Heart Rate Variability
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Auricular transcutaneous vagus nerve stimulation (Device)
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.
Intervention: Auricular transcutaneous vagus nerve stimulation (Device)
Outcomes
Primary Outcomes
Heart Rate Variability
Time Frame: 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 Outcomes
- 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).)
Investigators
Alper Percin
Lecturer
Bahçeşehir University