Hospital de Mataró
Mataró, Barcelona, 08304, Spain
NCT Number: NCT02422576
Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
Mataró, Barcelona, 08304, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to15 min after ingredient ingestion
Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time frame: up to15 min after ingredient ingestion
Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time frame: up to15 min after ingredient ingestion
Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time frame: up to15 min after ingredient ingestion
time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time frame: up to 20 min after ingredient ingestion
Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG.
Time frame: 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
Time frame: 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
Société des Produits Nestlé (SPN)
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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