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

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050957
• Other study ID #: MA01-11//2012
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2017
• Last updated: May 9, 2017
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2017
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Nervous System Diseases

Intervention

Dietary Supplement:
• menthol
Alimentary bolus supplemented with menthol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laryngeal vestibule closure time	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.