An interventional study of Capsaicin and Piperine in Oropharyngeal Dysphagia and Swallowing Disorder, sponsored by Hospital de Mataró. Not yet recruiting at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Hospital de Mataró · Not applicable, Interventional, and Treatment
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Hospital de Mataró is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Natural TRPV1 agonist at a concentration of 10mcM. Posology: 10 mL every 8h for 6 month.
Dietary Supplement: Capsaicin
Natural TRPA1/V1 agonist at a concentration of 150mcM. Posology: 10 mL every 8h for 6 month.
Dietary Supplement: Piperine
Deionized water + the same preservatives as in the active treatments
Dietary Supplement: Placebo
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: 1. Material does not enter the airway. 2. Material enters the airway. Remains above vocal cords and is ejected from the airway. 3. Material is above vocal cords and is not ejected from the airway. 4. Material enters the airway, contacts vocal cords and is ejected from the airway. 5. Material contacts the vocal cords and is not ejected from the airway. 6. Material passes below the vocal cords and is ejected into larynx or out of the airway. 7. Material passes below the vocal cords and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time frame: Pre treatment visit
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: 1. Material does not enter the airway. 2. Material enters the airway. Remains above vocal cords and is ejected from the airway. 3. Material is above vocal cords and is not ejected from the airway. 4. Material enters the airway, contacts vocal cords and is ejected from the airway. 5. Material contacts the vocal cords and is not ejected from the airway. 6. Material passes below the vocal cords and is ejected into larynx or out of the airway. 7. Material passes below the vocal cords and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time frame: 1 month follow-up visit
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: 1. Material does not enter the airway. 2. Material enters the airway. Remains above vocal cords and is ejected from the airway. 3. Material is above vocal cords and is not ejected from the airway. 4. Material enters the airway, contacts vocal cords and is ejected from the airway. 5. Material contacts the vocal cords and is not ejected from the airway. 6. Material passes below the vocal cords and is ejected into larynx or out of the airway. 7. Material passes below the vocal cords and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time frame: 3 month follow-up visit
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: 1. Material does not enter the airway. 2. Material enters the airway. Remains above vocal cords and is ejected from the airway. 3. Material is above vocal cords and is not ejected from the airway. 4. Material enters the airway, contacts vocal cords and is ejected from the airway. 5. Material contacts the vocal cords and is not ejected from the airway. 6. Material passes below the vocal cords and is ejected into larynx or out of the airway. 7. Material passes below the vocal cords and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time frame: 6 month follow-up visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time frame: Pre treatment visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time frame: 1 month follow-up visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time frame: 3 month follow-up visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time frame: 6 month follow-up visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time frame: Pre treatment visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time frame: 1 month follow-up visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time frame: 3 month follow-up visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time frame: 6 month follow-up visit
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: * Time to laryngeal vestibule closure * Time to upper esophageal sphincter opening * Time to laryngeal vestibule opening
Time frame: Pre treatment visit
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: * Time to laryngeal vestibule closure * Time to upper esophageal sphincter opening * Time to laryngeal vestibule opening
Time frame: 1 month follow-up visit
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: * Time to laryngeal vestibule closure * Time to upper esophageal sphincter opening * Time to laryngeal vestibule opening
Time frame: 3 month follow-up visit
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: * Time to laryngeal vestibule closure * Time to upper esophageal sphincter opening * Time to laryngeal vestibule opening
Time frame: 6 month follow-up visit
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time frame: Pre treatment visit
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time frame: 1 month follow-up visit
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time frame: 3 month follow-up visit
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time frame: 6 month follow-up visit
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time frame: Pre treatment visit
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time frame: 1 month follow-up visit
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time frame: 3 month follow-up visit
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time frame: 6 month follow-up visit
Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography and accelerometry for 10min to assess: the number of swallows per minute
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Hospital readmission rate
Hospital readmissions (readmissions/100 persons-year)
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Prevalence of lower respiratory tract infections
Lower respiratory tract infections (including pneumonia)
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Mortality
Mortality rate
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Responders rate
Responders were defined as those patients who, after treatment, achieved safe swallow at a lower level of viscosity or, at the same viscosity level, improved at least one point in the penetration-aspiration scale.
Time frame: 6 month follow-up visit
Treatment palatability: Taste
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the taste using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Time frame: 1, 3 and 6 month follow-up visits
Treatment palatability: Texture
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the texture using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Time frame: 1, 3 and 6 month follow-up visits
Treatment palatability: Future Adherence
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the possible future adherence to the treatment if prescribed using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Time frame: 1, 3 and 6 month follow-up visits
Salivary neuropeptides
Saliva samples will be collected in all study visits using the Salivette® technique, by putting a swab under the tongue for 5 min. The concentration of salivary neuropeptides substance P (SP) and calcitonin gene-related peptide (CGRP) will be determined by using 2 specific commercial Enzyme-Linked ImmunoSorbent Assay (ELISA) kits
Time frame: 1, 3 and 6 month follow-up visits
Treatment safety
Adverse events occurring during the study will be monitored according to the guideline of categories described by the world health organization
Time frame: From the inclusion to the study until the end of their participation (6 month)
Treatment compliance
A sample of urine will be collected at each study visit and the concentration of riboflavin (part of the composition of the product from the 3 groups) will be extrapolated with fluorescence.
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2023; primary completion for Dec 2025, 27 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 27 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Capsaicin · Piperine
Hospital de Mataró