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

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

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.

Study Overview

• Status: Completed
• Conditions: Vocal Cord Dysfunction; Paradoxical Vocal Fold Motion Disorder
• Intervention / Treatment: Behavioral: Respiratory retraining for PVFMD

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • BUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Respiratory retraining for PVFMD; Single arm study

Behavioral: Respiratory retraining for PVFMD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in respiratory minute volume using Spirometry pre and post therapy	This measure was chosen to quantify the volume (frequency and depth) of exchanged air to determine to what extent individuals who undergo the tested respiratory retraining technique change the rate and depth of respiration.	Measured on day 1, 21, 42 and 84
ETCO2 using Capnometry	ETCO2, or blood gas end tidal carbon dioxide, is considered a surrogate measure for arterial CO2 levels (Bowler, 1998; Gardner 1996). Increased levels of ETCO2 have been suggested to improve symptoms of hyperventilation caused by over-breathing (Courtney, 2008; Stark & Stark, 2002).	Measured on day 1, 21, 42 and 84
Heart rate using pulse oximetry and during home practice measured by the participants taking their pulse	A reduction in heart rate from pre-therapy to post-therapy may suggest decreased levels of arousal, which may also correlate with respiratory minute volume.	Measured on day 1, 21, and then measured three times daily till day 84
Control Pause (CP) or Steps	The CP/steps is a rough measure to determine the internal validity of the respiratory retraining program in the cohort with PVFMD. CP/Steps measures are proposed to be correlated with ETCO2 measurements (Stark & Stark, 2002, p.77; p. 113).	measured on day 1 and 21 and then measured three times daily till day 84

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: University of Haifa
• Investigators: Principal Investigator: Dana Halevi-Katz, BA-SLP, University of Haifa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Informaiton on vocal cord dysfunction by Jewish National Health

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 22, 2017
• Study Completion (Actual): May 22, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Paradoxical vocal fold motion disorder (PVFMD); vocal cord dysfunction (VCD); Respiratory retraining; Respiratory disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Disease; Vocal Cord Dysfunction
• Other Study ID Numbers: H-33940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No