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OpenTrials
Completed

NCT Number: NCT03050957

Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging

Oropharyngeal dysphagia (OD) is the most frequent digestive disorder in older people (>70 years) and has been recently recognized as a geriatric syndrome. The main features of OD are: a high prevalence and severe complications either related with the decreased swallowing efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50% prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50% of mortality rate. However, there is no specific pharmacologic treatment for OD in older patients yet. Treatments are now evolving from compensation to active treatments aiming to restore the swallowing dysfunction and some groups have been looking for new therapeutic strategies. The main goal of this study is to evaluate the effect of administering menthol in bolus on the swallowing response in elderly and neurogenic patients with OD. In addition, this study will also assess the side effects of this pharmacological strategy.

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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with suspicion of OD associated with aging (>70 years), neurodegenerative diseases or stroke.

Exclusion criteria

  • Patients with suspicion that they will not be able to compliment the protocol, patients participating or have participated in a clinical study the last 4 weeks and patients with alcoholic or drugs dependence

Treatment and study plan

menthol

Dietary Supplement

Alimentary bolus supplemented with menthol

Primary outcomes

  1. Laryngeal vestibule closure time

    Time frame: Laryngeal vestibule closure time is assessed during the videofluoroscopic assessment. Laryngeal vestibule closure time can occur between 100 milliseconds from the GPJ opening up to 1000 milliseconds.

    timing of the opening of the laryngeal vestibule (LV), glossopalatine junction (GPJ) opening being given the time value 0

Sponsors and collaborators

Lead sponsor

Hospital de Mataró

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 13, 2017
Registry last updated
May 10, 2017

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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