Impact of Auricular Vagus Nerve Neuromodulation on COVID-19 Positive Inpatients Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-09

Study Completion Date

2021-01-15

Brief Summary

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The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed.

A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome.

In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models.

Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities.

Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear.

Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

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Detailed Description

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Conditions

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Covid19 SARS-CoV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The participants and the care providers will not know the arm of randomization. Only the principal investigator who will perform the intervention will know the type of intervention.

Study Groups

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Auricular neuromodulation

Group Type EXPERIMENTAL

Auricular neuromodulation

Intervention Type PROCEDURE

The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room.

Ear disinfection and sterile neuromodulation needle placement (service protocol with Chlorhexidine) Placement of 4 semi-permanent Classic needles (SEDATELEC®) on each ear flap at the level of the concha (innervated by the vagus nerve) according to an order and a precise location (4 cardinal points conch), i.e. 8 needles per patient.

Compress soaked with Oxygenated water on the concha (to stop potential bleeding).

Placing an opaque dressing on the ear and a non-occlusive Band-Aid

Control

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room.

Ear disinfection and sterile manipulation without needle placement (service protocol with Chlorhexidine) No needle laying but only sterile disinfection and pressure over the 4 putative locations with the sterile plastic tip (without the needle).

Compress soaked with Oxygenated water on the concha. Placing an opaque dressing on the ear and a non-occlusive Band-Aid.

Interventions

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Auricular neuromodulation

The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room.

Ear disinfection and sterile neuromodulation needle placement (service protocol with Chlorhexidine) Placement of 4 semi-permanent Classic needles (SEDATELEC®) on each ear flap at the level of the concha (innervated by the vagus nerve) according to an order and a precise location (4 cardinal points conch), i.e. 8 needles per patient.

Compress soaked with Oxygenated water on the concha (to stop potential bleeding).

Placing an opaque dressing on the ear and a non-occlusive Band-Aid

Intervention Type PROCEDURE

Control

The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room.

Ear disinfection and sterile manipulation without needle placement (service protocol with Chlorhexidine) No needle laying but only sterile disinfection and pressure over the 4 putative locations with the sterile plastic tip (without the needle).

Compress soaked with Oxygenated water on the concha. Placing an opaque dressing on the ear and a non-occlusive Band-Aid.

Intervention Type PROCEDURE

Other Intervention Names

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VERUM SHAM

Eligibility Criteria

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Inclusion Criteria

* COVID-19 positive inpatient (PCR or other certified test mandatory)
* Inpatient showing at least one of the following criterion: Abnormal respiratory auscultation AND SpO2 \< 94% without oxygen therapy, OR Acute Respiratory failure requiring either oxygen therapy or high-flow oxygen therapy or non-invasive respirator and/or invasive respirator.

\- Unintentional blinding removal.