Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia
NCT ID: NCT04741620
Last Updated: 2022-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2019-01-17
2022-03-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Capsaicin 10microM
10mL capsaicin 10microM solution 3 times/day during 14 consecutive days (2 weeks).
Piperine 150microM (TRPV1 & TRPA1 natural agonist)
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
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.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM
10mL Piperine 150microM solution 3 times/day during 14 consecutive days (2 weeks).
Capsaicin 10microM (TRPV1 natural agonist)
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
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.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Cinnamaldehyde 756,6microM + zinc 70microM
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).
Capsaicin 10microM (TRPV1 natural agonist)
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM (TRPV1 & TRPA1 natural agonist)
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Citric acid 457,5microM (pH=3,5)
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 (TRPV1 natural agonist)
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM (TRPV1 & TRPA1 natural agonist)
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Capsaicin 10microM + Citric acid 457,5microM (pH=3,5)
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).
Capsaicin 10microM (TRPV1 natural agonist)
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM (TRPV1 & TRPA1 natural agonist)
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Placebo
10mL placebo solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks).
Capsaicin 10microM (TRPV1 natural agonist)
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM (TRPV1 & TRPA1 natural agonist)
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
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.
Interventions
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Capsaicin 10microM (TRPV1 natural agonist)
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
Piperine 150microM (TRPV1 & TRPA1 natural agonist)
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
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.
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.
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.
Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
70 Years
ALL
No
Sponsors
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Hospital de Mataró
OTHER
Responsible Party
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Pere Clave
Principal Investigator
Principal Investigators
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Pere Clavé, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Mataró
Locations
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Consorci Sanitari del Maresme (Hospital de Mataró)
Mataró, Barcelona, Spain
Countries
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References
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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.
Other Identifiers
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PI18/00241
Identifier Type: -
Identifier Source: org_study_id
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