Oropharyngeal DysphagiaFIS2018NCT04741620
Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia
A study testing Capsaicin 10microM (TRPV1 natural agonist), Piperine 150microM (TRPV1 & TRPA1 natural agonist) and Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist) in people with Oropharyngeal Dysphagia and Dysphagia, run by Hospital de Mataró at 1 site in Spain.
Trial summary
Oropharyngeal sensory impairments are a potential target for treatment of oropharyngeal dysphagia (OD) in older patients. We previously found acute administration of TRP sensory stimulants improved VFS signs and swallow response. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia, Dysphagia, Swallowing Disorder
- What is being tested?
- Capsaicin 10microM (TRPV1 natural agonist), Piperine 150microM (TRPV1 & TRPA1 natural agonist) and Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2019to 27 Mar 2022
- 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
- More than 70 years old.
- Oropharyngeal dysphagia with impaired safety of swallow (penetration aspiration score higher or equal than 2).
- Patients able to comply with the study protocol.
- Signature or the written informed consent.
Who cannot join
- Previous history of severe gastrointestinal diseases.
- Epilepsy or previous convulsive crisis episodes.
- Pacemaker or implanted defibrillator carriers.
- Cardiopulmonary instability.
- Oropharyngeal dysphagia of structural cause.
- Previous history of head and neck surgery.
Show all 13Show fewer
- Neurodegenerative disease.
- Advanced dementia (GDS higher than 5).
- Gastroesophageal reflux.
- Taking drugs with effects on dopamine.
- Neoplasia or active infection.
- Alcohol, tobacco or drugs dependence.
- Participate or have participated in another interventionist clinical trial in the 4 weeks prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari del Maresme (Hospital de Mataró)
Mataró, Barcelona, 08301
About this study
Official title: Subacute Effect of Pharmacological Sensory Stimulation of the Oropharynx by Agonists of TRP Receptors in Swallowing Neurophysiology in the Elderly With Oropharyngeal Dysphagia.
Oropharyngeal sensory impairments are a potential target for treatment of oropharyngeal dysphagia (OD) in older patients. We previously found acute administration of TRP sensory stimulants improved VFS signs and swallow response. We hypothesized that sub-acute administration of TRP pharyngeal sensory stimulants, would improve cortical neuroplasticity and will lead into a faster and stronger swallow response, however desensitization of TRP receptors may occur. Therefore, the aim of the present study was to assess the biomechanical (Videofluoroscopy) and neurophysiological (pharyngeal sensory evoked potentials -PSEPs- and motor-evoked potentials (MEPs)) effect of 2 week treatment with TRP agonists in older patients with OD. Design: 150 older (>70yr) patients with OD will be included in a Randomized Control Trial assessing the effect of oral administration of either: a) capsaicin (TRPV1); b) piperine (TRPV1/TRPA1) c) cinnamaldehyde (TRPA1); d) citric acid (ASIC3); e) capsaicin+citric acid (TRPV1/ASIC3); and f) placebo (Control). Measurements: 1) VFS signs of safety and efficacy of swallow and timing and extent of swallow response; 2) Latency, amplitude and cortical representation of PSEP and MEP; 3) Substance P concentration in saliva by ELISA as a marker of peripheral stimulation. Results from this study might help to develop new and effective pharmacological treatments for older dysphagic patients, from compensation to recovery of swallow function.
Read the detailed description
The project consists of a randomized, double-blind controlled interventional clinical trial (patient and analysis of results) with five treatment arms and a control group (placebo) involving a total of 150 elderly patients with oropharyngeal dysphagia (25 patients per group).
The recruitment of participants for the study will be carried out from the patients referred to the Dysphagia Unit of the Hospital de Mataró for the evaluation of swallowing disorders. The swallowing function of all candidates to be included in the study will be clinically evaluated using the volume-viscosity swallowing test (V-VST). Those patients with signs of impaired safety of swallowing during the examination (cough, decreased O2 saturation greater than 2% or voice change) will be candidates to participate in the study. They will be informed and in case of acceptance a saliva sample will be taken, and a videofluoroscopy (VFS) will be performed. If the patient presents impaired safety of swallow (Penetration aspiration scale higher or equal than 2), the patient will be definitively randomized to one of the branches of intervention and the rest of the explorations will proceed (sensory evoked potentials to pharyngeal electrical stimulation and pharyngeal motor evoked potentials to transcranial magnetic stimulation). After the treatment period a second evaluation of study procedures will be performed.
The treatment will consist of administering 10mL solution of the study product, according to randomization, 3 times a day (before breakfast, lunch and dinner) for 14 consecutive days after inclusion in the study. Treatment selected according our previous studies (Alvarez-Berdugo et al. Neurogastroenterol Motil 2017) are: Capsaicin 10microM, Piperine 150microM, Cinnamaldehyde 756,6microM + zinc 70microM, citric acid 457,5microM (pH=3,5), Capsaicin 10microM + citric acid 457,5microM (pH=3,5). For the control group, placebo product will be administered, which will be the vehicle solution with a more neutral pH.
- Conditions
- Oropharyngeal Dysphagia, Dysphagia, Swallowing Disorder
- Being tested
- Capsaicin 10microM (TRPV1 natural agonist), Piperine 150microM (TRPV1 & TRPA1 natural agonist), Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist), Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist), Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists)
- Keywords
- Oropharyngeal dysphagia, TRP agonists, Pharmacological stimulation, Sensory stimulation, Elderly
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 10microM (TRPV1 natural agonist)Other
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM (TRPV1 & TRPA1 natural agonist)Other
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist)Other
10 mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times per day (before each meal) during 14 consecutive days.
Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist)Other
10 mL Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.
Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists)Other
10 mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)Other
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin 10microM | Active comparator | 10mL capsaicin 10microM solution 3 times/day during 14 consecutive days (2 weeks). Receives: Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist); Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist); Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist); Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists); Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol) |
| Piperine 150microM | Active comparator | 10mL Piperine 150microM solution 3 times/day during 14 consecutive days (2 weeks). Receives: Other: Capsaicin 10microM (TRPV1 natural agonist); Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist); Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist); Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists); Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol) |
| Cinnamaldehyde 756,6microM + zinc 70microM | Active comparator | 10mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). Receives: Other: Capsaicin 10microM (TRPV1 natural agonist); Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist); Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist); Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists); Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol) |
| Citric acid 457,5microM (pH=3,5) | Active comparator | 10mL Citric acid 457,5microM (pH=3,5) solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). Receives: Other: Capsaicin 10microM (TRPV1 natural agonist); Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist); Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist); Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists); Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol) |
| Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) | Active comparator | 10mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). Receives: Other: Capsaicin 10microM (TRPV1 natural agonist); Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist); Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist); Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist); Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol) |
| Placebo | Placebo comparator | 10mL placebo solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). Receives: Other: Capsaicin 10microM (TRPV1 natural agonist); Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist); Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist); Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist); Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of the Penetration Aspiration Scale
Differences found in the videofluoroscopy Penetration Aspiration Scale (from 1 (safe swallow) to 8 (silent aspiration)) between treatments and vs. the placebo group.
Measured: Baseline versus 2/3 days after the intervention
Secondary outcomes (11)
Impaired safety of swallow
Videofluoroscopic signs of impaired safety of swallow (penetrations an aspirations)
Measured: Baseline versus 2/3 days after the intervention
Impaired efficacy
Videofluoroscopic signs of impaired efficacy of swallow (oral and pharyngeal residue)
Measured: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (laryngeal vestibule closure time)
Laryngeal vestibule closure time (ms) in videofluoroscopy
Measured: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (upper esophageal opening time)
Upper esophageal opening time (ms) in videofluoroscopy
Measured: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (laryngeal vestibule opening time)
Laryngeal vestibule opening time (ms) in videofluoroscopy
Measured: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (Bolus final velocity)
Bolus final velocity (m/s) in videofluoroscopy
Measured: Baseline versus 2/3 days after the intervention
Pharyngeal sensory evoked potentials
Latency and amplitude of N1, P1, N2 and P2 peaks of the Pharyngeal sensory evoked potentials.
Measured: Baseline versus 2/3 days after the intervention
Pharyngeal motor evoked potentials
Latency, amplitude, duration and area under de curve of the Pharyngeal motor evoked potentials.
Measured: Baseline versus 2/3 days after the intervention
Sensory threshold
Sensory threshold to pharyngeal electrical stimulation (mA)
Measured: Baseline versus 2/3 days after the intervention
Substance P
Concentration of substance P in saliva.
Measured: Baseline versus 2/3 days after the intervention
Palatability and comfort with the treatment.
Palatability and comfort with the treatment.
Measured: Baseline versus 2/3 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start17 Jan 2019
- Primary completion27 Mar 2022
- Study completion27 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Clave, Hospital de Mataró
- Investigators
- Pere Clavé, PhD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741620
- Sponsor's protocol ID
- PI18/00241
- Acronym
- FIS2018
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guanyabens N, Tomsen N, Palomeras E, Mundet L, Clave P, Ortega O. Neurophysiological characterization of oropharyngeal dysphagia in older patients. Clin Neurophysiol. 2024 Jun;162:129-140. doi: 10.1016/j.clinph.2024.03.030. Epub 2024 Apr 4.
PubMed 38615499
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacute Effect of Pharmacological Sensory Stimulation of the Oropharynx by Agonists of TRP Receptors in Swallowing Neurophysiology in the Elderly With Oropharyngeal Dysphagia.
- ClinicalTrials.gov ID
- NCT04741620
- Acronym / sponsor ID
- FIS2018 / PI18/00241
- Conditions
- Oropharyngeal Dysphagia, Dysphagia, Swallowing Disorder
- Keywords
- Oropharyngeal dysphagia, TRP agonists, Pharmacological stimulation, Sensory stimulation, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 27 Mar 2022 (actual)
- First posted
- 5 Feb 2021 (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.
Oropharyngeal sensory impairments are a potential target for treatment of oropharyngeal dysphagia (OD) in older patients. We previously found acute administration of TRP sensory stimulants improved VFS signs and swallow response. We hypothesized that sub-acute administration of TRP pharyngeal sensory stimulants, would improve cortical neuroplasticity and will lead into a faster and stronger swallow response, however desensitization of TRP receptors may occur. Therefore, the aim of the present study was to assess the biomechanical (Videofluoroscopy) and neurophysiological (pharyngeal sensory evoked potentials -PSEPs- and motor-evoked potentials (MEPs)) effect of 2 week treatment with TRP agonists in older patients with OD. Design: 150 older (>70yr) patients with OD will be included in a Randomized Control Trial assessing the effect of oral administration of either: a) capsaicin (TRPV1); b) piperine (TRPV1/TRPA1) c) cinnamaldehyde (TRPA1); d) citric acid (ASIC3); e) capsaicin+citric acid (TRPV1/ASIC3); and f) placebo (Control). Measurements: 1) VFS signs of safety and efficacy of swallow and timing and extent of swallow response; 2) Latency, amplitude and cortical representation of PSEP and MEP; 3) Substance P concentration in saliva by ELISA as a marker of peripheral stimulation. Results from this study might help to develop new and effective pharmacological treatments for older dysphagic patients, from compensation to recovery of swallow function.
Detailed description
The project consists of a randomized, double-blind controlled interventional clinical trial (patient and analysis of results) with five treatment arms and a control group (placebo) involving a total of 150 elderly patients with oropharyngeal dysphagia (25 patients per group).
The recruitment of participants for the study will be carried out from the patients referred to the Dysphagia Unit of the Hospital de Mataró for the evaluation of swallowing disorders. The swallowing function of all candidates to be included in the study will be clinically evaluated using the volume-viscosity swallowing test (V-VST). Those patients with signs of impaired safety of swallowing during the examination (cough, decreased O2 saturation greater than 2% or voice change) will be candidates to participate in the study. They will be informed and in case of acceptance a saliva sample will be taken, and a videofluoroscopy (VFS) will be performed. If the patient presents impaired safety of swallow (Penetration aspiration scale higher or equal than 2), the patient will be definitively randomized to one of the branches of intervention and the rest of the explorations will proceed (sensory evoked potentials to pharyngeal electrical stimulation and pharyngeal motor evoked potentials to transcranial magnetic stimulation). After the treatment period a second evaluation of study procedures will be performed.
The treatment will consist of administering 10mL solution of the study product, according to randomization, 3 times a day (before breakfast, lunch and dinner) for 14 consecutive days after inclusion in the study. Treatment selected according our previous studies (Alvarez-Berdugo et al. Neurogastroenterol Motil 2017) are: Capsaicin 10microM, Piperine 150microM, Cinnamaldehyde 756,6microM + zinc 70microM, citric acid 457,5microM (pH=3,5), Capsaicin 10microM + citric acid 457,5microM (pH=3,5). For the control group, placebo product will be administered, which will be the vehicle solution with a more neutral pH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Capsaicin 10microM | Active comparator | Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist), Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist), Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist), Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists), Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)10mL capsaicin 10microM solution 3 times/day during 14 consecutive days (2 weeks). |
| Piperine 150microM | Active comparator | Other: Capsaicin 10microM (TRPV1 natural agonist), Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist), Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist), Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists), Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)10mL Piperine 150microM solution 3 times/day during 14 consecutive days (2 weeks). |
| Cinnamaldehyde 756,6microM + zinc 70microM | Active comparator | Other: Capsaicin 10microM (TRPV1 natural agonist), Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist), Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist), Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists), Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)10mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). |
| Citric acid 457,5microM (pH=3,5) | Active comparator | Other: Capsaicin 10microM (TRPV1 natural agonist), Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist), Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist), Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists), Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)10mL Citric acid 457,5microM (pH=3,5) solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). |
| Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) | Active comparator | Other: Capsaicin 10microM (TRPV1 natural agonist), Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist), Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist), Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist), Other: Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)10mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). |
| Placebo | Placebo comparator | Other: Capsaicin 10microM (TRPV1 natural agonist), Other: Piperine 150microM (TRPV1 & TRPA1 natural agonist), Other: Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist), Other: Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist), Other: Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists)10mL placebo solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- More than 70 years old.
- Oropharyngeal dysphagia with impaired safety of swallow (penetration aspiration score higher or equal than 2).
- Patients able to comply with the study protocol.
- Signature or the written informed consent.
Key exclusion criteria (13 listed)
- Previous history of severe gastrointestinal diseases.
- Epilepsy or previous convulsive crisis episodes.
- Pacemaker or implanted defibrillator carriers.
- Cardiopulmonary instability.
- Oropharyngeal dysphagia of structural cause.
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 |
|---|---|---|
| Capsaicin 10microM (TRPV1 natural agonist)10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days. | Other | Capsaicin 10microM + Citric acid 457,5microM (pH=3,5), Cinnamaldehyde 756,6microM + zinc 70microM, Citric acid 457,5microM (pH=3,5), Piperine 150microM, Placebo |
| Piperine 150microM (TRPV1 & TRPA1 natural agonist)10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days. | Other | Capsaicin 10microM, Capsaicin 10microM + Citric acid 457,5microM (pH=3,5), Cinnamaldehyde 756,6microM + zinc 70microM, Citric acid 457,5microM (pH=3,5), Placebo |
| Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist)10 mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times per day (before each meal) during 14 consecutive days. | Other | Capsaicin 10microM, Capsaicin 10microM + Citric acid 457,5microM (pH=3,5), Citric acid 457,5microM (pH=3,5), Piperine 150microM, Placebo |
| Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist)10 mL Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days. | Other | Capsaicin 10microM, Capsaicin 10microM + Citric acid 457,5microM (pH=3,5), Cinnamaldehyde 756,6microM + zinc 70microM, Piperine 150microM, Placebo |
| Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists)10 mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days. | Other | Capsaicin 10microM, Cinnamaldehyde 756,6microM + zinc 70microM, Citric acid 457,5microM (pH=3,5), Piperine 150microM, Placebo |
| Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days. | Other | Capsaicin 10microM, Capsaicin 10microM + Citric acid 457,5microM (pH=3,5), Cinnamaldehyde 756,6microM + zinc 70microM, Citric acid 457,5microM (pH=3,5), Piperine 150microM |
Primary outcome
Change in the score of the Penetration Aspiration Scale
Time frame: Baseline versus 2/3 days after the intervention
Differences found in the videofluoroscopy Penetration Aspiration Scale (from 1 (safe swallow) to 8 (silent aspiration)) between treatments and vs. the placebo group.
11 secondary outcomes
Impaired safety of swallow
Time frame: Baseline versus 2/3 days after the intervention
Impaired efficacy
Time frame: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (laryngeal vestibule closure time)
Time frame: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (upper esophageal opening time)
Time frame: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (laryngeal vestibule opening time)
Time frame: Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (Bolus final velocity)
Time frame: Baseline versus 2/3 days after the intervention
Pharyngeal sensory evoked potentials
Time frame: Baseline versus 2/3 days after the intervention
Pharyngeal motor evoked potentials
Time frame: Baseline versus 2/3 days after the intervention
Sensory threshold
Time frame: Baseline versus 2/3 days after the intervention
Substance P
Time frame: Baseline versus 2/3 days after the intervention
Palatability and comfort with the treatment.
Time frame: Baseline versus 2/3 days after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Derived from this study: PubMed 38615499Guanyabens N, Tomsen N, Palomeras E, Mundet L, Clave P, Ortega O. Neurophysiological characterization of oropharyngeal dysphagia in older patients. Clin Neurophysiol. 2024 Jun;162:129-140. doi: 10.1016/j.clinph.2024.03.030. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No
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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.
Pere Clavé, PhD principal investigator
Hospital de Mataró
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 10microM (TRPV1 natural agonist), Piperine 150microM (TRPV1 & TRPA1 natural agonist) and Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist) in people with Oropharyngeal Dysphagia and Dysphagia, 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 13 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: finished, as of the sponsor's last update on 13 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the score of the Penetration Aspiration Scale (time frame: Baseline versus 2/3 days after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741620, which also lists 1 linked publication.
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 13 Jul 2022.