Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique (PVFMDRespRet)
Primary Purpose
Paradoxical Vocal Fold Motion Disorder, Vocal Cord Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respiratory retraining for PVFMD
Sponsored by
About this trial
This is an interventional treatment trial for Paradoxical Vocal Fold Motion Disorder focused on measuring Paradoxical vocal fold motion disorder (PVFMD), vocal cord dysfunction (VCD), Respiratory retraining, Respiratory disorders
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
Sites / Locations
- BUMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Respiratory retraining for PVFMD
Arm Description
Single arm study
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
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.
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).
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.
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).
Full Information
NCT ID
NCT02859974
First Posted
August 3, 2016
Last Updated
June 8, 2017
Sponsor
Boston Medical Center
Collaborators
University of Haifa
1. Study Identification
Unique Protocol Identification Number
NCT02859974
Brief Title
Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
Acronym
PVFMDRespRet
Official Title
Treatment of Exertion Induced Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
May 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
University of Haifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paradoxical Vocal Fold Motion Disorder, Vocal Cord Dysfunction
Keywords
Paradoxical vocal fold motion disorder (PVFMD), vocal cord dysfunction (VCD), Respiratory retraining, Respiratory disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiratory retraining for PVFMD
Arm Type
Experimental
Arm Description
Single arm study
Intervention Type
Behavioral
Intervention Name(s)
Respiratory retraining for PVFMD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Dyspnea Index (DI) score pre and post therapy
Description
a 10-item symptom-based questionnaire validated on individuals with upper airway pathology, including PVFMD (Gartner-Schmidt, Shembel, Zullo, & Rosen, 2014)
Time Frame
measured at four points: day 1, day 21, day 42 and day 84
Title
Change in the frequency and control of PVFMD patient-reported symptoms, pre and post therapy, measured by a daily log
Description
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
Time Frame
Measured daily for 84 days
Secondary Outcome Measure Information:
Title
Change in respiratory minute volume using Spirometry pre and post therapy
Description
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.
Time Frame
Measured on day 1, 21, 42 and 84
Title
ETCO2 using Capnometry
Description
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).
Time Frame
Measured on day 1, 21, 42 and 84
Title
Heart rate using pulse oximetry and during home practice measured by the participants taking their pulse
Description
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.
Time Frame
Measured on day 1, 21, and then measured three times daily till day 84
Title
Control Pause (CP) or Steps
Description
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).
Time Frame
measured on day 1 and 21 and then measured three times daily till day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Halevi-Katz, BA-SLP
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23337061
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.
Results Reference
background
PubMed Identifier
25836980
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.
Results Reference
background
PubMed Identifier
16112543
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.
Results Reference
result
Links:
URL
https://www.nationaljewish.org/healthinfo/conditions/Vocal-Cord-Dysfunction
Description
Informaiton on vocal cord dysfunction by Jewish National Health
Learn more about this trial
Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
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