Paradoxical Vocal Fold Motion DisorderPVFMDRespRetNCT02859974
Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
A study testing Respiratory retraining for PVFMD in people with Paradoxical Vocal Fold Motion Disorder and Vocal Cord Dysfunction, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Paradoxical Vocal Fold Motion Disorder, Vocal Cord Dysfunction
- What is being tested?
- Respiratory retraining for PVFMD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 22 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Exertion Induced 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.
- Being tested
- Respiratory retraining for PVFMD
- Keywords
- Paradoxical vocal fold motion disorder (PVFMD), vocal cord dysfunction (VCD), Respiratory retraining, Respiratory disorders
- Medical subject headings
- Vocal Cord Dysfunction, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory retraining for PVFMDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory retraining for PVFMD | Experimental | Single arm study Receives: Behavioral: Respiratory retraining for PVFMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured at four points: day 1, day 21, day 42 and day 84
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: Measured daily for 84 days
Secondary outcomes (4)
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: Measured on day 1, 21, 42 and 84
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: Measured on day 1, 21, 42 and 84
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: Measured on day 1, 21, and then measured three times daily till day 84
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: measured on day 1 and 21 and then measured three times daily till day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startSep 2015
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Paradoxical Vocal Fold Motion DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, Hadas Golan, Boston Medical Center
- Investigators
- Dana Halevi-Katz, BA-SLP, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859974
- Sponsor's protocol ID
- H-33940
- Acronym
- PVFMDRespRet
- Status last verified
- Jun 2017
- First submitted
- 3 Aug 2016
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23337061Patel 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.
PubMed 25836980Mathers-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.
PubMed 16112543
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Exertion Induced Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
- ClinicalTrials.gov ID
- NCT02859974
- Acronym / sponsor ID
- PVFMDRespRet / H-33940
- Keywords
- Paradoxical vocal fold motion disorder (PVFMD), vocal cord dysfunction (VCD), Respiratory retraining, Respiratory disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- Sep 2015
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory retraining for PVFMD | Experimental | Behavioral: Respiratory retraining for PVFMDSingle arm study |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory retraining for PVFMDPatients 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. | Behavioural | Respiratory retraining for PVFMD |
Primary outcome
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)
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
4 secondary outcomes
Change in respiratory minute volume using Spirometry pre and post therapy
Time frame: Measured on day 1, 21, 42 and 84
ETCO2 using Capnometry
Time frame: Measured on day 1, 21, 42 and 84
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
Control Pause (CP) or Steps
Time frame: measured on day 1 and 21 and then measured three times daily till day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Background: PubMed 23337061Hoyte 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.
- Background: PubMed 25836980Patel 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 publication: PubMed 16112543Mathers-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.
- Informaiton on vocal cord dysfunction by Jewish National HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Paradoxical Vocal Fold Motion Disorder
RecruitingPhase 2
Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion
Exercise-Induced Vocal Cord Dysfunction, Paradoxical Vocal Fold Motion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Halevi-Katz, BA-SLP principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory retraining for PVFMD in people with Paradoxical Vocal Fold Motion Disorder and Vocal Cord Dysfunction, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02859974, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.