Post-COVID-19 SyndromeNCT05764070
Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post SARS-CoV-2 Patients
A study testing non-invasive auricular vagus stimulation in people with Post-COVID-19 Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- non-invasive auricular vagus stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2023to 4 Aug 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
- No healthy volunteers
- Adult
Who may be able to join
- Covid
- be between 18-45 years old
- Having pulmonary involvement in the covid process
Who cannot join
- Being a professional in any sport
- Having a cardiopulmonary, orthopedic, neurological and metabolic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahçeşehir University
Istanbul, Istanbul Avrupa Kitasi, 34353
About this study
Official title: Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients
Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. Extended Covid-19 syndrome, also known as Post-Covid-19 syndrome, is described as
Read the detailed description
Therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal, cardiovascular and neurological well-being and the prevention and treatment of chronic diseases. The effects of therapeutic exercises on the human body varied according to the frequency, intensity, duration and type of exercise.
Increasing physiological and psychological recovery after exercise can lead to results such as better performance and reducing the risk of injury. Therefore, various methods are used to facilitate post-exercise recovery.
The best-known and most widely used post-exercise recovery method is active cooling, also known as active rest or cool-down. Active cooling; It is defined as any activity that includes voluntary, low/moderate intensity exercise or movement performed within one hour of exercise. Passive rest, on the other hand, is defined as no or minimal voluntary/intentional exercise movement.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- non-invasive auricular vagus stimulation, Placebo Non Invasive Vagus Stimulation
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive auricular vagus stimulationDevice
The only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased.
Placebo Non Invasive Vagus StimulationDevice
Placebo Non Invasive Vagus Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Non Invasive Vagus Stimulation | Experimental | Aerobic exercise + Non Invasive- Vagus Stimulation Receives: Device: non-invasive auricular vagus stimulation |
| Placebo Non Invasive Vagus Stimulation | Placebo comparator | Aerobic exercise + Placebo Non Invasive Vagus Stimulation Receives: Device: Placebo Non Invasive Vagus Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
In the measurement of pain intensity, it was planned to use a standard, 10 mm VAS with proven reliability. The severity of pain felt by the patient; It is a scale used to mark 0 = no pain and 10 = the most severe pain, thus determining the patient's pain intensity subjectively.
Measured: a day
Autonomic nervous system device (Polar H10)
The Polar H10 device is a heart rate sensor that comes with a wearable chest strap and is the gold standard of high sensitivity and accuracy. It can be connected to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that touches the chest to capture the heart rate in real time.
In the study, the autonomic nervous system will be evaluated with the Polar H10 device. By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data.
Measured: a day
Lactate Analysis
It was measured with a portable lactate analyzer before and after exercise training, just before the recovery phase. It is an ideal lactate analyzer for using metabolic information to assess endurance, design optimal training programs, avoid overtraining plans and help identify target heart rate zones.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start9 Mar 2023
- Primary completion9 Mar 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764070
- Sponsor's protocol ID
- SARS-CoV-2
- Status last verified
- Aug 2023
- First submitted
- 9 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McNarry MA, Berg RMG, Shelley J, Hudson J, Saynor ZL, Duckers J, Lewis K, Davies GA, Mackintosh KA. Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial. Eur Respir J. 2022 Oct 6;60(4):2103101. doi: 10.1183/13993003.03101-2021. Print 2022 Oct.
PubMed 35236727
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients
- ClinicalTrials.gov ID
- NCT05764070
- Acronym / sponsor ID
- SARS-CoV-2
- Conditions
- Post-COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 10 Mar 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.
Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. Extended Covid-19 syndrome, also known as Post-Covid-19 syndrome, is described as
Detailed description
Therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal, cardiovascular and neurological well-being and the prevention and treatment of chronic diseases. The effects of therapeutic exercises on the human body varied according to the frequency, intensity, duration and type of exercise.
Increasing physiological and psychological recovery after exercise can lead to results such as better performance and reducing the risk of injury. Therefore, various methods are used to facilitate post-exercise recovery.
The best-known and most widely used post-exercise recovery method is active cooling, also known as active rest or cool-down. Active cooling; It is defined as any activity that includes voluntary, low/moderate intensity exercise or movement performed within one hour of exercise. Passive rest, on the other hand, is defined as no or minimal voluntary/intentional exercise movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Invasive Vagus Stimulation | Experimental | Device: non-invasive auricular vagus stimulationAerobic exercise + Non Invasive- Vagus Stimulation |
| Placebo Non Invasive Vagus Stimulation | Placebo comparator | Device: Placebo Non Invasive Vagus StimulationAerobic exercise + Placebo Non Invasive Vagus Stimulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Covid
- be between 18-45 years old
- Having pulmonary involvement in the covid process
Key exclusion criteria (2 listed)
- Being a professional in any sport
- Having a cardiopulmonary, orthopedic, neurological and metabolic disease
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 |
|---|---|---|
| non-invasive auricular vagus stimulationThe only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. | Device | Non Invasive Vagus Stimulation |
| Placebo Non Invasive Vagus StimulationPlacebo Non Invasive Vagus Stimulation | Device | Placebo Non Invasive Vagus Stimulation |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: a day
In the measurement of pain intensity, it was planned to use a standard, 10 mm VAS with proven reliability. The severity of pain felt by the patient; It is a scale used to mark 0 = no pain and 10 = the most severe pain, thus determining the patient's pain intensity subjectively.
Autonomic nervous system device (Polar H10)
Time frame: a day
The Polar H10 device is a heart rate sensor that comes with a wearable chest strap and is the gold standard of high sensitivity and accuracy. It can be connected to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that touches the chest to capture the heart rate in real time. In the study, the autonomic nervous system will be evaluated with the Polar H10 device. By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data.
Lactate Analysis
Time frame: one day
It was measured with a portable lactate analyzer before and after exercise training, just before the recovery phase. It is an ideal lactate analyzer for using metabolic information to assess endurance, design optimal training programs, avoid overtraining plans and help identify target heart rate zones.
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 14 Aug 2023.
- Background: PubMed 35236727McNarry MA, Berg RMG, Shelley J, Hudson J, Saynor ZL, Duckers J, Lewis K, Davies GA, Mackintosh KA. Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial. Eur Respir J. 2022 Oct 6;60(4):2103101. doi: 10.1183/13993003.03101-2021. Print 2022 Oct.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive auricular vagus stimulation in people with Post-COVID-19 Syndrome, run by Istanbul Medipol University Hospital 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 3 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 14 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (VAS) (time frame: a day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764070, which also lists 1 linked publication.
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 14 Aug 2023.