Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
- Conditions
- Paradoxical Vocal Fold Motion DisorderVocal Cord Dysfunction
- Interventions
- Behavioral: Respiratory retraining for PVFMD
- Registration Number
- NCT02859974
- Lead Sponsor
- Boston Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Respiratory retraining for PVFMD Respiratory retraining for PVFMD Single arm study
- Primary Outcome Measures
Name Time Method Change in Dyspnea Index (DI) score pre and post therapy measured at four points: day 1, day 21, day 42 and day 84 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 Measured daily for 84 days 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
Name Time Method ETCO2 using Capnometry Measured on day 1, 21, 42 and 84 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 Measured on day 1, 21, and then measured three times daily till day 84 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.
Change in respiratory minute volume using Spirometry pre and post therapy Measured on day 1, 21, 42 and 84 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.
Control Pause (CP) or Steps measured on day 1 and 21 and then measured three times daily till day 84 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).
Trial Locations
- Locations (1)
BUMC
🇺🇸Boston, Massachusetts, United States