Clinical trial NCT02422576: Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia
Official title: Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-04-21
Enrollment: 104
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of the safety of the swallowing function, according to Rosenbek's scale
timeFrame: up to15 min after ingredient ingestion
Secondary outcomes:
measure: Swallowing safety-Prevalence of penetration
timeFrame: up to15 min after ingredient ingestion
measure: Swallowing safety-Prevalence of aspiration
timeFrame: up to15 min after ingredient ingestion
measure: Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues
timeFrame: up to15 min after ingredient ingestion
measure: Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues
timeFrame: up to15 min after ingredient ingestion
measure: Efficacy of swallowing function-Time to upper oesophageal sphincter opening
timeFrame: up to15 min after ingredient ingestion
measure: Efficacy of swallowing function-Time to laryngeal vestibule opening
timeFrame: up to15 min after ingredient ingestion
measure: Efficacy of swallowing function-time to laryngeal vestibule closure
timeFrame: up to15 min after ingredient ingestion
measure: Modification of brain physiology response to sensory input:
timeFrame: up to 20 min after ingredient ingestion
measure: 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).
timeFrame: ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested
measure: palatability using a questionnaire, assessed during EEG sessions (V3 and V4)
timeFrame: ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
Study officials:
affiliation: Hospital de Mataro
name: Pere Clavé, Md/PhD
role: PRINCIPAL_INVESTIGATOR
References: