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A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by CAMC Health System
Sponsor:
Information provided by (Responsible Party):
Safina Kureshi, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01916616
First received: August 1, 2013
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while inhaling. Children and adolescents with VCD may experience multiple symptoms, including difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited information on optimal management of VCD. In our proposed study, we will use cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity will be examined prior to and following a series of four therapy sessions with a clinical psychologist that are focused on teaching patients strategies to decrease symptom reactivity.


Condition Intervention
Vocal Cord Dysfunction
Behavioral: Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study

Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Change in frequency and intensity of VCD symptoms [ Time Frame: Post intervention at 1 to 3 weeks ] [ Designated as safety issue: No ]
    Self-reported number of symptomatic episodes and mean intensity of episodes pre and post-CBT intervention will be compared. Symptom intensity will be measured using an 11 point Likert Scale for self-reported distress for each recorded VCD episode.


Secondary Outcome Measures:
  • Change in pulmonary function testing (PFT) measures [ Time Frame: Post intervention at 1 to 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques
    At the four therapy sessions, subjects will work with the psychologist to identify the triggers of their VCD episodes, learn to self-monitor symptoms and reactions, and be taught breathing retraining/relaxation techniques. The goal is to decrease patterns of subjects' thinking or behaviors that exacerbate distress from VCD symptoms.
  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent patients presenting to West Virginia University, Charleston Division Sub-specialty Clinic for Pediatric Pulmonology with a clinical diagnosis of vocal cord dysfunction.
  • Diagnosed with VCD within 12 months prior to study enrollment. between the ages of 13 and 18 years old.
  • Currently symptomatic for VCD.
  • Must have a baseline PFT to reference at the time of diagnosis. Additionally in patients who were diagnosed with VCD 6 months or more prior to study enrollment, current PFT results as part of routine care, are required.
  • A parent or guardian must agree to participate in the four behavioral therapy sessions with his or her child.

Exclusion Criteria:

  • Severe psychiatric disorders (ex. psychosis, suicidal ideation)
  • Developmental delay
  • Previous speech therapy for the treatment of VCD.
  • Currently receiving psychological counseling.
  • In open Child Protective Services cases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916616

Locations
United States, West Virginia
Department of Pediatric, West Virginia University-Charleston Division Recruiting
Charleston, West Virginia, United States, 25302
Contact: Kevin Maupin, MD    304-388-1552    kdmaupin@hsc.wvu.edu   
Contact: Stephanie Thompson, PhD    (304) 388-9911    stethompson@camc.org   
Principal Investigator: Kevin Maupin, MD         
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Kevin Maupin, MD WVU Charleston Division
  More Information

No publications provided

Responsible Party: Safina Kureshi, CAMC Medical Staff-with admitting privileges, CAMC Health System
ClinicalTrials.gov Identifier: NCT01916616     History of Changes
Other Study ID Numbers: 1997292
Study First Received: August 1, 2013
Last Updated: September 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
paradoxical vocal fold motion
cognitive-behavioral therapy

Additional relevant MeSH terms:
Vocal Cord Dysfunction
Laryngeal Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014