Long COVIDNCT05679505
Vagus Nerve Stimulation for Post-COVID Syndrome
A study testing Auricular transcutaneous vagus nerve stimulation in people with Long COVID and Vagus Nerve Stimulations, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Vagus Nerve Stimulations, Heart Rates
- What is being tested?
- Auricular transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Oct 2022to 4 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18 years or older
- Experiencing at least one of the post-covid symptoms for 12 weeks or longer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vagus Nerve Stimulation in Post-COVID-19 Syndrome: A Randomized Controlled Trial
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?
Read more
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
- Being tested
- Auricular transcutaneous vagus nerve stimulation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular transcutaneous vagus nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Auricular transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start27 Oct 2022
- Primary completion1 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Percin, Bahçeşehir University
- Investigators
- Ramazan Erenler, Prof. Dr., Study chair, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679505
- Sponsor's protocol ID
- STUDY003
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Stimulation in Post-COVID-19 Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05679505
- Acronym / sponsor ID
- STUDY003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left ear transcutaneous vagus nerve stimulation | Experimental | Device: Auricular transcutaneous vagus nerve stimulationLeft 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 | Experimental | Device: Auricular transcutaneous vagus nerve stimulationBilateral 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being 18 years or older
- Experiencing at least one of the post-covid symptoms for 12 weeks or longer
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular transcutaneous vagus nerve stimulationTranscutaneous 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. | Device | Bilateral double ear transcutaneous vagus nerve stimulation, Left ear transcutaneous vagus nerve stimulation |
Primary outcome
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.
1 secondary outcome
Fatigue Severity Scale
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan Erenler, Prof. Dr. study chair
Igdir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular transcutaneous vagus nerve stimulation in people with Long COVID and Vagus Nerve Stimulations, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.