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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 13, 2017
Last Update Posted Date May 10, 2017
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging
Official Title  ICMJE Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Deglutition Disorders
Intervention  ICMJE Dietary Supplement: menthol
Alimentary bolus supplemented with menthol
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: 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
    Intervention: Dietary Supplement: menthol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2017)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03050957
Other Study ID Numbers  ICMJE MA01-11//2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pere Clave, Hospital de Mataró
Study Sponsor  ICMJE Hospital de Mataró
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital de Mataró
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP