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NCT07074964: TMBruxism
Manual Therapy in Vagus Nerve Neuromodulation for the Treatment of Bruxism
NA trial testing Autonomic nervous system intervention in Bruxism, Sleep in 40 participants. Not yet recruiting.
1 October 2027
Quick facts
| Lead sponsor | Escoles Universitaries Gimbernat |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 October 2025 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 December 2028 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Autonomic nervous system intervention
- Slight finger pressure
Conditions studied
- Bruxism, Sleep — all drugs for Bruxism, Sleep →
Sponsor
Escoles Universitaries Gimbernat
Who can join
Adults 18 to 40, any sex, with Bruxism, Sleep. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction: Sleep bruxism is defined as the repetitive activity of the masticatory muscles, characterized by clenching or grinding of the teeth. Studies confirm the association between sleep bruxism and episodes of masticatory muscle activity, with an increase in autonomic sympathetic activity observed during transient periods of sleep. This is associated with nocturnal awakenings, related to increased cardiac, cerebral (cortical arousal), respiratory, and muscular activity. Objectives: The main objectives are "To study the mean power frequency (MPF) of the masticatory muscles measured by surface electromyography (sEMG) in the general population (with and without bruxism according to ICSD-3 and DC/TMD criteria)"; and "to assess the effectiveness of manual therapy applied to structures adjacent to the vagus nerve based on its impact on orofacial pain and symptomatology in patients with bruxism". Material and Methods: A cross-sectional observational study and a randomized controlled experimental study were designed. The first will analyze data collected by sEMG in the masticatory muscles, at rest and during maximum clenching, comparing results between bruxists and non-bruxists. The second will analyze, compared to the control group, data collected on signs (range of motion alteration, presence of sounds), symptomatology (pain, headaches, sensation of blockage, functional limitation) caused by bruxism, sleep quality (Pittsburgh Sleep Quality Index (PSQI)), oral health-related quality of life (OHIP-14), stress and anxiety status (Perceived Stress Scale and GAD-7 (Generalized Anxiety Disorder-7), respectively), and sympathetic-vagal balance (Heart Rate Variability in its frequency and time domains) before and after a manual therapy intervention on structures adjacent to the vagus nerve pathway (head, neck, thorax, diaphragm, abdomen). The collected data will be analyzed using IBM SPSS® version 25.0.0.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07074964
- Europe PMC full search
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Related trials
Other Escoles Universitaries Gimbernat trials
Trials by the same sponsor.
- NCT07070947 — Surface Electromyography in the Detection and Assessment of Bruxism · not yet recruiting
- NCT06619028 — External Body Weight Effects on Body Weight in Adults With Grade II and III Obesity · NA · not yet recruiting
- NCT05942417 — Echoguided Percutaneous Neuromodulation in the Management of Chronic Ankle Instability in Physically Active Subjects. · NA · completed
- NCT05283447 — Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia · NA · completed
- NCT05649566 — Intervention of Virtual Reality on Oculomotor Muscles and Balance · NA · completed
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 NCT07074964 (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 Escoles Universitaries Gimbernat
- Last refreshed: 24 July 2025
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/NCT07074964.
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