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

Vocal Cord Dysfunction Clinical Trial

— PVFMDRespRet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859974
• Other study ID #: H-33940
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: June 8, 2017
• Start date: September 2015
• Est. completion date: May 22, 2017

Study information

• Verified date: June 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Paradoxical Vocal Fold Motion Disorder
• Vocal Cord Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	BUMC	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	University of Haifa

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Mathers-Schmidt BA, Brilla LR. Inspiratory muscle training in exercise-induced paradoxical vocal fold motion. J Voice. 2005 Dec;19(4):635-44. Epub 2005 Aug 19. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Informaiton on vocal cord dysfunction by Jewish National Health