NCT02547051

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

September 8, 2015

Last Update Submit

October 10, 2017

Conditions

Vocal Cord TensionDysfluency Developmental

Outcome Measures

Primary Outcomes (1)

  • Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension

    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.

    1 Year

Study Arms (1)

Food allergy and vocal cord tension

EXPERIMENTAL

To determine if dietary allergen responses and frequency and severity of vocal cord tension.

Other: Food Allergy Testing and Elimination Diet

Interventions

Food Allergy Testing and Elimination DietOTHER

Food allergy testing and elimination diet

Food allergy and vocal cord tension

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients reporting persistent developmental disfluency.

You may not qualify if:

  • Patients reporting no changes in disfluency severity or frequency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

R2 Institute

Houston, Texas, 77007, United States

Location

MeSH Terms

Interventions

Elimination Diets

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Yohan R, Medical Doctor

CONTACT

9174096426yohanrr@auamed.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 11, 2015

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

February 1, 2022

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

US(1)