Oropharyngeal DysphagiaNCT05958173
Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD
A study testing Capsaicin and Piperine in people with Oropharyngeal Dysphagia and Swallowing Disorder, run by Hospital de Mataró at 1 site in Spain.
Trial summary
In recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (OD). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia, Swallowing Disorder
- What is being tested?
- Capsaicin and Piperine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥70 years
- With a positive Volume-Viscosity Swallow Test for oropharyngeal dysphagia
- Penetration-aspiration scale >1 in videofluoroscopy
- Able to follow the protocol and to give written informed consent.
Who cannot join
- Life expectancy < 3m or palliative care
- Allergy to iodinated contrast or to the components of the treatment solutions
- Cancer or active infection
- Implanted electronic device
- Epilepsy
- Metal in the head
- Participation in another clinical trial (previous month).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical, Neurophysiological and Clinical Effects of 6-month Stimulation Using TRPV1 and TRPA1 Agonists in Older Patients With Oropharyngeal Dysphagia
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.
- Conditions
- Oropharyngeal Dysphagia, Swallowing Disorder
- Being tested
- Capsaicin, Piperine, Placebo
- Keywords
- TRP agonists, Sensory stimulation, Rehabilitation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDietary supplement
Oral stimulation with natural TRPV1 agonist
PiperineDietary supplement
Oral stimulation with natural TRPA1/V1 agonist
PlaceboDietary supplement
Oral stimulation with placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Active comparator | Natural TRPV1 agonist at a concentration of 10mcM. Posology: 10 mL every 8h for 6 month. Receives: Dietary Supplement: Capsaicin |
| Piperine | Active comparator | Natural TRPA1/V1 agonist at a concentration of 150mcM. Posology: 10 mL every 8h for 6 month. Receives: Dietary Supplement: Piperine |
| Placebo | Placebo comparator | Deionized water + the same preservatives as in the active treatments Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy:
- Material does not enter the airway.
- Material enters the airway. Remains above vocal cords and is ejected from the airway.
- Material is above vocal cords and is not ejected from the airway.
- Material enters the airway, contacts vocal cords and is ejected from the airway.
- Material contacts the vocal cords and is not ejected from the airway.
- Material passes below the vocal cords and is ejected into larynx or out of the airway.
- Material passes below the vocal cords and is not ejected from the trachea despite effort.
- Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Measured: Pre treatment visit
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy:
- Material does not enter the airway.
- Material enters the airway. Remains above vocal cords and is ejected from the airway.
- Material is above vocal cords and is not ejected from the airway.
- Material enters the airway, contacts vocal cords and is ejected from the airway.
- Material contacts the vocal cords and is not ejected from the airway.
- Material passes below the vocal cords and is ejected into larynx or out of the airway.
- Material passes below the vocal cords and is not ejected from the trachea despite effort.
- Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Measured: 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:
- Material does not enter the airway.
- Material enters the airway. Remains above vocal cords and is ejected from the airway.
- Material is above vocal cords and is not ejected from the airway.
- Material enters the airway, contacts vocal cords and is ejected from the airway.
- Material contacts the vocal cords and is not ejected from the airway.
- Material passes below the vocal cords and is ejected into larynx or out of the airway.
- Material passes below the vocal cords and is not ejected from the trachea despite effort.
- Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Measured: 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:
- Material does not enter the airway.
- Material enters the airway. Remains above vocal cords and is ejected from the airway.
- Material is above vocal cords and is not ejected from the airway.
- Material enters the airway, contacts vocal cords and is ejected from the airway.
- Material contacts the vocal cords and is not ejected from the airway.
- Material passes below the vocal cords and is ejected into larynx or out of the airway.
- Material passes below the vocal cords and is not ejected from the trachea despite effort.
- Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Measured: 6 month follow-up visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Measured: Pre treatment visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Measured: 1 month follow-up visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Measured: 3 month follow-up visit
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Measured: 6 month follow-up visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Measured: Pre treatment visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Measured: 1 month follow-up visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Measured: 3 month follow-up visit
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 month follow-up visit
Secondary outcomes (11)
Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography and accelerometry for 10min to assess: the number of swallows per minute
Measured: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Hospital readmission rate
Hospital readmissions (readmissions/100 persons-year)
Measured: 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)
Measured: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Mortality
Mortality rate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Pre treatment visit and 1, 3 and 6 month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, double-blinded, three-arm randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Clave, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958173
- Sponsor's protocol ID
- PI22/01101
- Status last verified
- Jul 2023
- First submitted
- 23 May 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical, Neurophysiological and Clinical Effects of 6-month Stimulation Using TRPV1 and TRPA1 Agonists in Older Patients With Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT05958173
- Acronym / sponsor ID
- PI22/01101
- Conditions
- Oropharyngeal Dysphagia, Swallowing Disorder
- Keywords
- TRP agonists, Sensory stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Single-center, double-blinded, three-arm randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Active comparator | Dietary Supplement: CapsaicinNatural TRPV1 agonist at a concentration of 10mcM. Posology: 10 mL every 8h for 6 month. |
| Piperine | Active comparator | Dietary Supplement: PiperineNatural TRPA1/V1 agonist at a concentration of 150mcM. Posology: 10 mL every 8h for 6 month. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDeionized water + the same preservatives as in the active treatments |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥70 years
- With a positive Volume-Viscosity Swallow Test for oropharyngeal dysphagia
- Penetration-aspiration scale >1 in videofluoroscopy
- Able to follow the protocol and to give written informed consent.
Key exclusion criteria (7 listed)
- Life expectancy < 3m or palliative care
- Allergy to iodinated contrast or to the components of the treatment solutions
- Cancer or active infection
- Implanted electronic device
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsaicinOral stimulation with natural TRPV1 agonist | Dietary supplement | Capsaicin |
| PiperineOral stimulation with natural TRPA1/V1 agonist | Dietary supplement | Piperine |
| PlaceboOral stimulation with placebo solution | Dietary supplement | Placebo |
Primary outcome
Severity of oropharyngeal dysphagia
Time frame: Pre treatment visit
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
Severity of oropharyngeal dysphagia
Time frame: 1 month follow-up visit
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
Severity of oropharyngeal dysphagia
Time frame: 3 month follow-up visit
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
Severity of oropharyngeal dysphagia
Time frame: 6 month follow-up visit
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
Safety impairment signs
Time frame: Pre treatment visit
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Safety impairment signs
Time frame: 1 month follow-up visit
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Safety impairment signs
Time frame: 3 month follow-up visit
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Safety impairment signs
Time frame: 6 month follow-up visit
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Efficacy impairment signs
Time frame: Pre treatment visit
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Efficacy impairment signs
Time frame: 1 month follow-up visit
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Efficacy impairment signs
Time frame: 3 month follow-up visit
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Efficacy impairment signs
Time frame: 6 month follow-up visit
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Swallow biomechanics
Time frame: Pre treatment visit
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
Swallow biomechanics
Time frame: 1 month follow-up visit
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
Swallow biomechanics
Time frame: 3 month follow-up visit
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
Swallow biomechanics
Time frame: 6 month follow-up visit
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
Pharyngeal sensory evoked potential (pSEP)
Time frame: Pre treatment visit
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.
Pharyngeal sensory evoked potential (pSEP)
Time frame: 1 month follow-up visit
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.
Pharyngeal sensory evoked potential (pSEP)
Time frame: 3 month follow-up visit
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.
Pharyngeal sensory evoked potential (pSEP)
Time frame: 6 month follow-up visit
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.
Pharyngeal motor evoked potentials (pMEP)
Time frame: Pre treatment visit
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).
Pharyngeal motor evoked potentials (pMEP)
Time frame: 1 month follow-up visit
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).
Pharyngeal motor evoked potentials (pMEP)
Time frame: 3 month follow-up visit
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).
Pharyngeal motor evoked potentials (pMEP)
Time frame: 6 month follow-up visit
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).
11 secondary outcomes
Spontaneous swallowing frequency (SSF)
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Hospital readmission rate
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Prevalence of lower respiratory tract infections
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Clinical outcomes: Mortality
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Responders rate
Time frame: 6 month follow-up visit
Treatment palatability: Taste
Time frame: 1, 3 and 6 month follow-up visits
Treatment palatability: Texture
Time frame: 1, 3 and 6 month follow-up visits
Treatment palatability: Future Adherence
Time frame: 1, 3 and 6 month follow-up visits
Salivary neuropeptides
Time frame: 1, 3 and 6 month follow-up visits
Treatment safety
Time frame: From the inclusion to the study until the end of their participation (6 month)
Treatment compliance
Time frame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Oropharyngeal Dysphagia
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
RecruitingPhase 2
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Dysphagia, Stroke
Recruiting
K01 Impacts of Lingual Endurance Exercise
Dysphagia, Dysphagia, Oropharyngeal
RecruitingPhase 2
Adaptive RadioTherapy for OroPharynx Cancer
Oropharynx Cancer, Radiotherapy; Complications
Recruiting
Tongue-strengthening Exercises in People With ALS.
ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin and Piperine in people with Oropharyngeal Dysphagia and Swallowing Disorder, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pere Clavé, PhD (937417700 ext. 2284, pere.clave@ciberehd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of oropharyngeal dysphagia (time frame: Pre treatment visit). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.