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VAGUS NERVE STIMULATION FOR POST COVID-19 SYNDROME

Primary Purpose

Long COVID, Vagus Nerve Stimulations, Heart Rates

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Auricular transcutaneous vagus nerve stimulation
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Iğdır State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Left ear transcutaneous vagus nerve stimulation

Bilateral double ear transcutaneous vagus nerve stimulation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 5, 2023
Last Updated
January 10, 2023
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05679505
Brief Title
VAGUS NERVE STIMULATION FOR POST COVID-19 SYNDROME
Official Title
EFFECTS OF VAGUS NERVE STIMULATION IN POST COVID-19 SYNDROME: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID, Vagus Nerve Stimulations, Heart Rates, Autonomic Nervous System Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left ear transcutaneous vagus nerve stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Bilateral double ear transcutaneous vagus nerve stimulation
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Auricular transcutaneous vagus nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
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.
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).
Secondary Outcome Measure Information:
Title
Fatigue Severity Scale
Description
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).
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Iğdır State Hospital
City
Iğdır
ZIP/Postal Code
76000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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VAGUS NERVE STIMULATION FOR POST COVID-19 SYNDROME

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