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NCT05630040 · ClinicalTrials.gov registry record · NA
VNS for Long-COVID-19
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05630040: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05630040 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630040, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function. This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.
Primary Outcome
COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widesp
Interventions
- DEVICE Sham Intervention
- DEVICE Non-invasive vagus nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-11-11 |
| Est. Completion | 2024-10-03 |
| Phase | NA |
What the finished NCT05630040 record still lists
NCT05630040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Intervention is the first listed.
NCT05630040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05630040 about?
NCT05630040 is a clinical study titled "VNS for Long-COVID-19". The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function. This will be a placebo controlled,...
What is the current status of trial NCT05630040?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-11-11. Estimated completion is 2024-10-03.
What interventions are being tested in trial NCT05630040?
The interventions under investigation include: Sham Intervention (DEVICE), Non-invasive vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT05630040?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05630040's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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