Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique

NCT02859974 | Completed

• 1 other identifier: H-33940
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Paradoxical Vocal Fold Motion Disorder (PVFMD), otherwise known as vocal cord dysfunction (VCD) is a laryngeal breathing disorder that has several potential causes. In some individuals, exertion is the predominant trigger. PVFMD can present like an asthma attack, but asthma medication is ineffective in treating it. The effects of untreated PVFMD can be devastating, leading to harmful, invasive, and ineffective treatments over a period of years. Numerous anecdotal reports indicate that several behavioral techniques, may be surprisingly effective and even curative. However, data are lacking. The form of respiratory retraining technique tested in the current study educates people with PVFMD about breathing and teaches them a number of breathing exercises specially designed to restore normal breathing patterns. This case series study will use a dyspnea perception questionnaire, patient daily logs, and physiological measurements of heart rate and breathing to examine whether this form of therapy can improve exertion-induced PVFMD symptoms.

Conditions

Paradoxical Vocal Fold Motion Disorder; Vocal Cord Dysfunction

Keywords

Paradoxical vocal fold motion disorder (PVFMD); vocal cord dysfunction (VCD); Respiratory retraining; Respiratory disorders

Outcome Measures

Primary Outcomes (2)

• Change in Dyspnea Index (DI) score pre and post therapy

  a 10-item symptom-based questionnaire validated on individuals with upper airway pathology, including PVFMD (Gartner-Schmidt, Shembel, Zullo, \& Rosen, 2014)

  measured at four points: day 1, day 21, day 42 and day 84

• Change in the frequency and control of PVFMD patient-reported symptoms, pre and post therapy, measured by a daily log

  The log will reflect participants' perceptions of frequency of PVFMD symptoms and their severity and ability to control them, using a three-item questionnaire using visual analogue scales (VAS) created by the investigators

  Measured daily for 84 days

Secondary Outcomes (4)

• Change in respiratory minute volume using Spirometry pre and post therapy

  Measured on day 1, 21, 42 and 84

• ETCO2 using Capnometry

  Measured on day 1, 21, 42 and 84

• Heart rate using pulse oximetry and during home practice measured by the participants taking their pulse

  Measured on day 1, 21, and then measured three times daily till day 84

• Control Pause (CP) or Steps

  measured on day 1 and 21 and then measured three times daily till day 84

Study Arms (1)

Respiratory retraining for PVFMD

EXPERIMENTAL

Single arm study

Behavioral: Respiratory retraining for PVFMD

Interventions

Respiratory retraining for PVFMD BEHAVIORAL

Patients serve as their own controls. During a three week baseline, participants will complete the Dyspnea Index (DI), and have their heart rate, Resp. minute volume and ETCO2 on days 1 and 21 (or on the day treatment commences). Participants will complete a "daily log" reporting their daily symptoms. This will serve as the baseline "pre"phase. Post 1 phase will include five individual therapy sessions teaching the respiratory retraining techniques over an estimated three week period. Post2 phase will comprise of a six week home practice phase. There will be four measuring points per participant: pre1/pre2 measurements on day 1 and 21 (or on the day therapy begins), post1 upon completing five therapy sessions and post 2 upon completion of the home practice phase.

Respiratory retraining for PVFMD

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy according to available medical history or by patient and parent report on the health questionnaire
• Patients with no history of asthma, or well-controlled asthma
• A diagnosis of PVFMD by an otolaryngologist based on set criteria in-line with the National Jewish PVFMD diagnostics protocol (based on Hicks, 2008; Hoyte, 2013, Martin, 1987), to be confirmed by an additional otolaryngologist blinded to the initial diagnosis
• A score of three or more on the dyspnea index (DI)

You may not qualify if:

• A score of less than three on the DI
• People diagnosed with hypertension, cardiac disorders or severe pulmonary diseases which affect blood oxygen saturation
• Uncontrolled asthma

Sponsors & Collaborators

• Boston Medical Center: lead
• University of Haifa: collaborator

Study Sites (1)

BUMC

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• Hoyte FC. Vocal cord dysfunction. Immunol Allergy Clin North Am. 2013 Feb;33(1):1-22. doi: 10.1016/j.iac.2012.10.010. Epub 2012 Dec 21.

  PMID: 23337061 BACKGROUND

• Patel RR, Venediktov R, Schooling T, Wang B. Evidence-Based Systematic Review: Effects of Speech-Language Pathology Treatment for Individuals With Paradoxical Vocal Fold Motion. Am J Speech Lang Pathol. 2015 Aug;24(3):566-84. doi: 10.1044/2015_AJSLP-14-0120.

  PMID: 25836980 BACKGROUND

• Mathers-Schmidt BA, Brilla LR. Inspiratory muscle training in exercise-induced paradoxical vocal fold motion. J Voice. 2005 Dec;19(4):635-44. doi: 10.1016/j.jvoice.2005.03.005. Epub 2005 Aug 19.

  PMID: 16112543 RESULT

Related Links

• Informaiton on vocal cord dysfunction by Jewish National Health

MeSH Terms

Conditions

Vocal Cord Dysfunction; Respiration Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Dana Halevi-Katz, BA-SLP

  University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CCC-SLP Hadas Golan

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 9, 2016
• Study Start: September 1, 2015
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Locations

US (1)