Vagus Nerve Stimulation for Post-COVID Syndrome

NCT05679505 | Completed

• 1 other identifier: STUDY003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Long COVID; Vagus Nerve Stimulations; Heart Rates; Autonomic Nervous System Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (2)

Left ear transcutaneous vagus nerve stimulation

EXPERIMENTAL

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

Bilateral double ear transcutaneous vagus nerve stimulation

EXPERIMENTAL

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

Interventions

Auricular transcutaneous vagus nerve stimulation 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; Left ear transcutaneous vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being 18 years or older
• Experiencing at least one of the post-covid symptoms for 12 weeks or longer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Iğdır State Hospital

Iğdır, 76000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Ramazan Erenler, Prof. Dr.

  Igdir University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 11, 2023
• Study Start: October 27, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 4, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)