Vocal Cord Dysfunction Clinical Trial
— PVFMDRespRetOfficial title:
Treatment of Exertion Induced Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
Verified date | June 2017 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | BUMC | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | University of Haifa |
United States,
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
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 |
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