Dysphagia
Conditions
Brief summary
Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors.
Detailed description
The trial will be double-blind, randomized, monocentric, and interventional with a hybrid design. The subjects will be randomized to one of the three parallel active ingredient groups. Products will be compared versus control (Thicken Up Clear - nectar viscosity), which adds a part of cross over within the design. The total sample size is 84 enrolled subjects. Patients will be males and females aged 55+ with mild proven dysphagia.
Interventions
OTHERcinnamon extract
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
OTHERlemon extract
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
OTHERlemon extract plus eucalyptus extract
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
OTHERThicken Up clear: TUC
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 55+ * Patients showing impaired safety of the deglutition during the V-VST (volume - viscosity swallow test): Cough oxygen desaturation ≥3% or voice change. * Neurodegenerative or ischemic/hemorrhagic cerebral cause (stroke) or elderly subjects
Exclusion criteria
* Patients radiated for treatment of head and neck cancer Idiosyncrasis * Allergy to food or medication, especially contrast products (iodine) * Major respiratory disease needing oxygen as standard treatment. * Any major and relevant abdominal, head and neck, or chest surgery within the three months preceding the study. * Have a high alcohol consumption (more than 2 drinks/day) * Subject who cannot be expected to comply with the study procedures, including consuming the test products. * Currently participating or having participated in another clinical trial during the month preceding the study * Patients with relevant mucosal damage or with in-mouth irritation * Patients with pacemaker or electrode implants * Epileptic patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of the safety of the swallowing function, according to Rosenbek's scale | up to15 min after ingredient ingestion | The maximum PAS score across the different boluses (5, 10 and 20 ml) during nectar series (with and without active ingredient) assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing safety-Prevalence of aspiration | up to15 min after ingredient ingestion | the prevalence of aspiration in the population according to Rosenbek's PAS (scores of 6-8), assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
| Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues | up to15 min after ingredient ingestion | Severity of the amount of oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
| Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues | up to15 min after ingredient ingestion | Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
| Efficacy of swallowing function-Time to upper oesophageal sphincter opening | up to15 min after ingredient ingestion | Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
| Swallowing safety-Prevalence of penetration | up to15 min after ingredient ingestion | the prevalence of penetration in the population according to Rosenbek's PAS (scores of 2-5) , assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
| Efficacy of swallowing function-time to laryngeal vestibule closure | up to15 min after ingredient ingestion | time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
| Modification of brain physiology response to sensory input: | up to 20 min after ingredient ingestion | Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG. |
| Tolerability to the products (gastrointestinal comfort) using a questionnaire, assessed during EEG sessions (V3 and V4) to avoid capturing side effects of the contrast agent (as nausea). | ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested | using questionnaire |
| palatability using a questionnaire, assessed during EEG sessions (V3 and V4) | ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested | using questionnaire |
| Efficacy of swallowing function-Time to laryngeal vestibule opening | up to15 min after ingredient ingestion | Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. |
Countries
Spain
Outcome results
None listed