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NCT Number: NCT02859974

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

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.

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Key information

Conditions

Paradoxical Vocal Fold Motion Disorder Laryngeal Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Tract Diseases Vocal Cord Dysfunction

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BUMC

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory retraining for PVFMD

Behavioral

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 outcomes

  1. Change in Dyspnea Index (DI) score pre and post therapy

    Time frame: 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)

  2. Change in the frequency and control of PVFMD patient-reported symptoms, pre and post therapy, measured by a daily log

    Time frame: 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 outcomes

  1. Change in respiratory minute volume using Spirometry pre and post therapy

    Time frame: 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.

  2. ETCO2 using Capnometry

    Time frame: 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).

  3. Heart rate using pulse oximetry and during home practice measured by the participants taking their pulse

    Time frame: 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.

  4. Control Pause (CP) or Steps

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • University of Haifa

Registry information

Official study title

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

Acronym: PVFMDRespRet

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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