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Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.

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ClinicalTrials.gov Identifier: NCT02547051
Recruitment Status : Not yet recruiting
First Posted : September 11, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
The R2 Institute

Brief Summary:
The purpose of this study is to see whether participants with persistent developmental disfluency who report fluctuational disfluency due to vocal cord tension on a day to day basis of can achieve a more normalized fluency by identifying dietary allergen responses and subsequently eliminating these dietary triggers from their daily consumption.

Condition or disease Intervention/treatment Phase
Vocal Cord Tension Dysfluency Developmental Other: Food Allergy Testing and Elimination Diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Factors and Disfluency. A Look Into Causes and Variations in Severity of Disfluency in Regards to Vocal Cord Tension.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Food allergy and vocal cord tension
To determine if dietary allergen responses and frequency and severity of vocal cord tension.
Other: Food Allergy Testing and Elimination Diet
Food allergy testing and elimination diet



Primary Outcome Measures :
  1. Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension [ Time Frame: 1 Year ]

    Initial fluency samples are taken prior to treatment protocol of study.

    Food sensitivity panel will be assessed for potential allergans. Allergan responses are graded from 0 being no response to food allergen to 3 being the strongest response and subsequent removal of sensitive allergan from diet. Speech sample and disfluency severity will be evaluated qualitatively again via the SSI-3 on repeat office visit at fixed interval scale. Erickson S-24 repeated at end of study and final conclusions made.




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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients reporting persistent developmental disfluency.

Exclusion Criteria:

  • Patients reporting no changes in disfluency severity or frequency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547051


Contacts
Contact: Yohan R, Medical Doctor 9174096426 yohanrr@auamed.net

Locations
United States, Texas
R2 Institute Recruiting
Houston, Texas, United States, 77007
Sponsors and Collaborators
The R2 Institute

Responsible Party: The R2 Institute
ClinicalTrials.gov Identifier: NCT02547051     History of Changes
Other Study ID Numbers: R2001AA
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No