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

May 9, 2017 updated by: Pere Clave, Hospital de Mataró
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Mataró

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ACTUAL)

February 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA01-11//2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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