Status:
COMPLETED
Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia
Lead Sponsor:
Hospital de Mataró
Conditions:
Oropharyngeal Dysphagia
Dysphagia
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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 VF...
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04741620
Start Date
January 17 2019
End Date
March 27 2022
Last Update
July 13 2022
Active Locations (1)
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1
Consorci Sanitari del Maresme (Hospital de Mataró)
Mataró, Barcelona, Spain, 08301