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

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ClinicalTrials.gov Identifier: NCT03050957
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deglutition Disorders Dietary Supplement: menthol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging
Actual Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: menthol 10 mM (millimolar)
Patients were studied during the deglutition of one series of 5, 10 and 20 mL nectar control boluses and two series of 5, 10 and 20 mL nectar boluses supplemented with the corresponding concentration of menthol 10 mM
Dietary Supplement: menthol
Alimentary bolus supplemented with menthol

Experimental: menthol 1 mM
Patients were studied during the deglutition of one series of 5, 10 and 20 mL nectar control boluses and two series of 5, 10 and 20 mL nectar boluses supplemented with the corresponding concentration of menthol 1 mM
Dietary Supplement: menthol
Alimentary bolus supplemented with menthol




Primary Outcome Measures :
  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



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Pere Clave, PhD, MD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT03050957     History of Changes
Other Study ID Numbers: MA01-11//2012
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Nervous System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Menthol
Antipruritics
Dermatologic Agents