Clinical trial NCT02859974: Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
Official title: Treatment of Exertion Induced Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paradoxical Vocal Fold Motion Disorder
Vocal Cord Dysfunction
Keywords: Paradoxical vocal fold motion disorder (PVFMD)
vocal cord dysfunction (VCD)
Respiratory retraining
Respiratory disorders
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2016-08-09
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Dyspnea Index (DI) score pre and post therapy
timeFrame: measured at four points: day 1, day 21, day 42 and day 84
measure: Change in the frequency and control of PVFMD patient-reported symptoms, pre and post therapy, measured by a daily log
timeFrame: Measured daily for 84 days
Secondary outcomes:
measure: Change in respiratory minute volume using Spirometry pre and post therapy
timeFrame: Measured on day 1, 21, 42 and 84
measure: ETCO2 using Capnometry
timeFrame: Measured on day 1, 21, 42 and 84
measure: Heart rate using pulse oximetry and during home practice measured by the participants taking their pulse
timeFrame: Measured on day 1, 21, and then measured three times daily till day 84
measure: Control Pause (CP) or Steps
timeFrame: measured on day 1 and 21 and then measured three times daily till day 84
Other outcomes:
Locations:
city: Boston
country: United States
facility: BUMC
state: Massachusetts
Study officials:
affiliation: University of Haifa
name: Dana Halevi-Katz, BA-SLP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.