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
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Sponsor:
Hospital de Mataró
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró
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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 |
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Deglutition Disorders | Dietary Supplement: menthol | Phase 2 |
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 |
Arm | Intervention/treatment |
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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
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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 :
- 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
No Contacts or Locations Provided
Responsible Party: | Pere Clave, PhD, MD, Hospital de Mataró |
ClinicalTrials.gov Identifier: | NCT03050957 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Deglutition Disorders Nervous System Diseases Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Pharyngeal Diseases Otorhinolaryngologic Diseases Menthol Antipruritics Dermatologic Agents |