Last reviewed · How we verify
NCT05958173
Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD
NA trial testing Capsaicin in Oropharyngeal Dysphagia in 150 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Hospital de Mataró |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 September 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
Conditions studied
- Oropharyngeal Dysphagia — all drugs for Oropharyngeal Dysphagia →
- Swallowing Disorder — all drugs for Swallowing Disorder →
Sponsor
Hospital de Mataró
Who can join
70 and older, any sex, with Oropharyngeal Dysphagia or Swallowing Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (OD). The investigators have demonstrated the acute and sub-acute therapeutic effect of TRP agonists on mechanical and neural swallow responses in patients with OD. The present hypothesis is that 6-months treatment with TRPV1 (capsaicin) or TRPA1 (piperine) agonists will improve the biomechanics and neurophysiology of the swallow response without inducing desensitization. The aim of this study is to evaluate the effect on biomechanics assessed by videofluoroscopy (VFS), neurophysiology (pharyngeal evoked sensory potentials -pSEP- and motor evoked potentials -pMEP-), and clinical outcomes during a 6-month treatment with TRP agonists added to the alimentary bolus 3 times a day in older patients with OD. Design: 150 older patients (\>70y) with OD will be included in a randomized clinical trial with three treatment arms, in which the effect of oral administration of 1) capsaicin 10µM (TRPV1 agonist), 2) piperine 150µM (TRPA1), and 3) placebo (Control), will be evaluated. Measurements: 1) VFS signs of swallowing safety and efficacy and timing of swallow response ; 2) Spontaneous swallowing frequency; 3) Latency, amplitude and cortical representation of pSEP and pMEP; 4) Concentration of substance P and CGRP in saliva, 5) Clinical outcomes (respiratory and nutritional complications). The results of this study will increase evidence for a new generation of pharmacological treatments for older patients with OD, moving from compensation to rehabilitation of the swallowing function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05958173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Capsaicin
Trials testing the same drug.
- NCT07237022 — The Role of TRP Channels in DPN · recruiting
- NCT06809569 — A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Health · Phase 1 · completed
- NCT05983263 — Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia · unknown
- NCT05543837 — Capsaicin for Cerebral Perfusion Augmentation · Phase 2 · completed
- NCT05298202 — The Influence of Capsaicin Gel During Exercise Within the Heat · Phase 4 · completed
Other recruiting trials for Oropharyngeal Dysphagia
Currently open trials in the same condition.
- NCT06309602 — Investigation of a Free Water Protocol · NA · recruiting
- NCT06814457 — Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia · NA · recruiting
- NCT05421689 — Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia · Phase 1, PHASE2 · active not recruiting
- NCT05278039 — Training Swallowing Initiation During Expiration · NA · recruiting
- NCT04477460 — Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event · recruiting
Other Hospital de Mataró trials
Trials by the same sponsor.
- NCT07192328 — Dose-Efficacy of rTMS in Healthy Young Female Volunteers · NA · completed
- NCT06217211 — Eficacia Ventilatoria y Remolacha · NA · unknown
- NCT06250426 — Effect of a Cooling Sensation Flavor on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia · NA · unknown
- NCT04739891 — Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors · unknown
- NCT04425759 — Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses (COVID-19) · unknown
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 NCT05958173 (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 Hospital de Mataró
- Last refreshed: 24 July 2023
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/NCT05958173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing