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NCT04341649
Multi-device Testing for Autonomic Nervous System Stimulation
NA trial testing Manual Head Massage in Vagus Nerve Stimulation in 15 participants. Completed in 24 March 2020.
23 March 2020
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 April 2019 |
| Primary completion | 23 March 2020 |
| Estimated completion | 24 March 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Manual Head Massage
- BREO Helmet Massager
- Low Laser Therapy (LLT)
- Sham LLT
- TENS ear stimulation
- Deep and Slow breathing
- Relaxed Reading time
Conditions studied
- Vagus Nerve Stimulation — all drugs for Vagus Nerve Stimulation →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 20 to 40, any sex, with Vagus Nerve Stimulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Vagus nerve (VN) serve as an "unconscious inner brain" that integrates messages from the body and provides metabolic homeostatic regulation to various organs.In this study the investigators want to compare different ways to stimulate the vagus nerve to assess their respective effects compared to a sham stimulation. Each participant will be exposed in a random way to 7 different ways to stimulate the VN: * Manual Head Massage * Mechanical Head Massager (BREO Inc. Helmet) * Low laser Therapy (LLT) * Sham LLT * Transcutaneous Electrical Nervous Stimulation (TENS) ear stimulation (as testing phase prototype device) * Deep and slow breathing (as testing intervention based on video app) * Relaxed reading time (as control situation) Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications: * Study 1: comparison of manual head massage to mechanical Helmet massager and relaxed reading * Study 2: comparison of LLT with sham LLT and relaxed reading The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04341649
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vagus Nerve Stimulation
Currently open trials in the same condition.
- NCT07118956 — Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease · NA · recruiting
- NCT06421051 — Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients. · NA · recruiting
- NCT06421077 — Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients · NA · recruiting
- NCT06421090 — Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients · NA · recruiting
- NCT05680337 — Auricular Vagus Stimulation and Heart Rate Variability · NA · recruiting
Other Beijing Tiantan Hospital trials
Trials by the same sponsor.
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- NCT07520370 — Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor · NA · not yet recruiting
- NCT07526987 — Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis · Phase 3 · not yet recruiting
- NCT07591207 — The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04341649 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 15 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04341649.
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