Paradoxical Vocal Fold MotionNCT05770518
Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion
A study testing Biofeedback in people with Paradoxical Vocal Fold Motion and Vocal Cord Dysfunction, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Paradoxical Vocal Fold Motion (PVFM) is a condition where vocal cords adduct (move toward another) instead of abduct (move away from one another) during inspiration, thus causing shortness of breath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction
- What is being tested?
- Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 30 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or older
- Referral to the Washington University School of Medicine Voice and Airway Center for concerns for PVFM
- Pre-treatment Dyspnea Index score of 11 or higher (representing the threshold for having an abnormal score)
- Answer yes to the following questions: "Do you sometimes have difficulty breathing?" and "When you have difficulty breathing, is it worse when inhaling (breathing in)?"
Who cannot join
- Inability to speak or understand English
- Previous treatment of PVFM
- History of laryngeal surgery
- Evidence of alternative laryngeal pathology (e.g. subglottic stenosis, benign or malignant obstructive mass) on flexible laryngoscopy as performed as part of routine clinical care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion (BLiMP)
Paradoxical Vocal Fold Motion (PVFM) is a condition where vocal cords adduct (move toward another) instead of abduct (move away from one another) during inspiration, thus causing shortness of breath. The goal of this pilot randomized controlled trial is to compare the efficacy of biofeedback as compared to laryngeal control therapy (LCT) in the treatment of PVFM. Participants will take surveys about their symptoms and their expectations of treatment prior to initiating treatment and after completion of their assigned treatment. Researchers will compare the biofeedback group to the LCT group to see if participants have differences in changes of their symptoms.
Read the detailed description
Paradoxical vocal fold motion (PVFM) is characterized by episodic shortness of breath that can range in severity and acuity. Symptoms may greatly impact daily life. Some patients experience severe respiratory distress, which can lead to emergency department visits and occasionally intubation. The standard treatment is typically behavioral therapy performed by speech and language pathologists. However, new evidence suggests that video biofeedback may be an effective alternative treatment. Video biofeedback allows patients to directly visualize their breathing while performing specific breathing exercises. This is a desirable treatment because it can be performed at the time of diagnosis and requires minimal additional time or resources. The investigators' goal is to conduct a pilot randomized controlled trial (RCT) to compare the relative effectiveness of video biofeedback and behavioral therapy in the treatment of PVFM. The primary endpoint will be the change in Dyspnea Index score before treatment and one month after treatment. Patients will complete surveys to collate data about patient expectations of behavioral therapy, their reasons for pursuing additional treatment if applicable, and the perceived benefits of the specific intervention. The investigators hypothesize that no clinically meaningful difference will be detected between behavioral therapy and video biofeedback for the treatment of PVFM. This pilot RCT will provide critical data for designing a fully powered trial comparing these two interventions, and will advance the investigators' goal of providing clinicians with important evidence for guiding treatment.
- Being tested
- Biofeedback, Laryngeal control therapy (LCT)
- Keywords
- laryngeal control therapy, biofeedback, dyspnea, stridor, dysphonia, cough, laryngoscopy
- Medical subject headings
- Vocal Cord Dysfunction, Dyspnea, Respiratory Sounds, Dysphonia, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Also called Video biofeedback
Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy.
Laryngeal control therapy (LCT)Behavioural
Also called respiratory retraining
This treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | In office video biofeedback performed at the time of the diagnosis. Receives: Behavioral: Biofeedback |
| Laryngeal control therapy | Active comparator | A specific type of behavioral therapy performed by speech and language pathologists Receives: Behavioral: Laryngeal control therapy (LCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Index (DI)
This is a 10-item questionnaire with scores that range from 0-40, with 40 representing the greatest possible severity of symptoms.
The DI is a clinical assessment tool that was designed and validated specifically for patients with upper airway obstruction, including patients with PVFM.
The primary outcome measure will be the difference between the two groups in the change in Dyspnea Index (DI).
Measured: pre and 1 month post treatment
Secondary outcomes (4)
Dyspnea Index (DI)
This is a 10-item questionnaire with scores that range from 0-40, with 40 representing the greatest possible severity of symptoms.
The DI is a clinical assessment tool that was designed and validated specifically for patients with upper airway obstruction, including patients with PVFM.
The primary outcome measure will be the difference between the two groups in the change in Dyspnea Index (DI).
Measured: pre and 3 months post treatment
Responder rates
Responder rate is the proportion of subjects at 1 month post-treatment whose Dyspnea Index scores have decreased by at least the minimal clinically important difference.
Measured: 1 month and 3 months post treatment
The Clinical Global Impressions - Improvement (CGI-I)
This is a widely used research rating tool which will be used to assess the response to treatment using a 7-point Likert scale. A score of 1 represents maximal improvement of symptoms, and a score of 7 represents maximal worsening of symptoms. Language has been adapted to represent participants' changes in breathing quality.
Measured: 1 month and 3 months post treatment
Qualitative Survey
The investigators will ask participants questions about their expectations of treatment, reasons for pursuing additional treatment if applicable, and perceived utility of their treatment.
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start7 Mar 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Paradoxical Vocal Fold MotionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial with active treatment control group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Huston, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770518
- Sponsor's protocol ID
- 202210154
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George S, Suresh S. Vocal Cord Dysfunction: Analysis of 27 Cases and Updated Review of Pathophysiology & Management. Int Arch Otorhinolaryngol. 2019 Apr;23(2):125-130. doi: 10.1055/s-0038-1661358. Epub 2018 Oct 24.
PubMed 30956693Kramer S, deSilva B, Forrest LA, Matrka L. Does treatment of paradoxical vocal fold movement disorder decrease asthma medication use? Laryngoscope. 2017 Jul;127(7):1531-1537. doi: 10.1002/lary.26416. Epub 2016 Nov 15.
PubMed 27861929Guglani L, Atkinson S, Hosanagar A, Guglani L. A systematic review of psychological interventions for adult and pediatric patients with vocal cord dysfunction. Front Pediatr. 2014 Aug 8;2:82. doi: 10.3389/fped.2014.00082. eCollection 2014.
PubMed 25152871Mahoney J, Hew M, Vertigan A, Oates J. Treatment effectiveness for Vocal Cord Dysfunction in adults and adolescents: A systematic review. Clin Exp Allergy. 2022 Mar;52(3):387-404. doi: 10.1111/cea.14036. Epub 2021 Nov 4.
PubMed 34699093Shaffer M, Litts JK, Nauman E, Haines J. Speech-Language Pathology as a Primary Treatment for Exercise-Induced Laryngeal Obstruction. Immunol Allergy Clin North Am. 2018 May;38(2):293-302. doi: 10.1016/j.iac.2018.01.003. Epub 2018 Mar 2.
PubMed 29631737Patel 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 25836980Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
PubMed 25311596LeBlanc RA, Aalto D, Jeffery CC. Visual biofeedback for paradoxical vocal fold motion (PVFM). J Otolaryngol Head Neck Surg. 2021 Feb 18;50(1):13. doi: 10.1186/s40463-021-00495-0.
PubMed 33602342De Guzman V, Ballif CL, Maurer R, Hartnick CJ, Raol N. Validation of the dyspnea index in adolescents with exercise-induced paradoxical vocal fold motion. JAMA Otolaryngol Head Neck Surg. 2014 Sep;140(9):823-8. doi: 10.1001/jamaoto.2014.1405.
PubMed 25104182Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Strober WA, Rohlfing ML, Cutchin GM, Kallogjeri D, Piccirillo JF, Huston MN. Biofeedback vs Respiratory Retraining for Inducible Laryngeal Obstruction: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Feb 1;152(2):182-190. doi: 10.1001/jamaoto.2025.4542.
PubMed 41379457
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion (BLiMP)
- ClinicalTrials.gov ID
- NCT05770518
- Acronym / sponsor ID
- 202210154
- Keywords
- laryngeal control therapy, biofeedback, dyspnea, stridor, dysphonia, cough, laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- 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 (PVFM) is a condition where vocal cords adduct (move toward another) instead of abduct (move away from one another) during inspiration, thus causing shortness of breath. The goal of this pilot randomized controlled trial is to compare the efficacy of biofeedback as compared to laryngeal control therapy (LCT) in the treatment of PVFM. Participants will take surveys about their symptoms and their expectations of treatment prior to initiating treatment and after completion of their assigned treatment. Researchers will compare the biofeedback group to the LCT group to see if participants have differences in changes of their symptoms.
Detailed description
Paradoxical vocal fold motion (PVFM) is characterized by episodic shortness of breath that can range in severity and acuity. Symptoms may greatly impact daily life. Some patients experience severe respiratory distress, which can lead to emergency department visits and occasionally intubation. The standard treatment is typically behavioral therapy performed by speech and language pathologists. However, new evidence suggests that video biofeedback may be an effective alternative treatment. Video biofeedback allows patients to directly visualize their breathing while performing specific breathing exercises. This is a desirable treatment because it can be performed at the time of diagnosis and requires minimal additional time or resources. The investigators' goal is to conduct a pilot randomized controlled trial (RCT) to compare the relative effectiveness of video biofeedback and behavioral therapy in the treatment of PVFM. The primary endpoint will be the change in Dyspnea Index score before treatment and one month after treatment. Patients will complete surveys to collate data about patient expectations of behavioral therapy, their reasons for pursuing additional treatment if applicable, and the perceived benefits of the specific intervention. The investigators hypothesize that no clinically meaningful difference will be detected between behavioral therapy and video biofeedback for the treatment of PVFM. This pilot RCT will provide critical data for designing a fully powered trial comparing these two interventions, and will advance the investigators' goal of providing clinicians with important evidence for guiding treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial with active treatment control group
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: BiofeedbackIn office video biofeedback performed at the time of the diagnosis. |
| Laryngeal control therapy | Active comparator | Behavioral: Laryngeal control therapy (LCT)A specific type of behavioral therapy performed by speech and language pathologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 or older
- Referral to the Washington University School of Medicine Voice and Airway Center for concerns for PVFM
- Pre-treatment Dyspnea Index score of 11 or higher (representing the threshold for having an abnormal score)
- Answer yes to the following questions: "Do you sometimes have difficulty breathing?" and "When you have difficulty breathing, is it worse when inhaling (breathing in)?"
Key exclusion criteria (4 listed)
- Inability to speak or understand English
- Previous treatment of PVFM
- History of laryngeal surgery
- Evidence of alternative laryngeal pathology (e.g. subglottic stenosis, benign or malignant obstructive mass) on flexible laryngoscopy as performed as part of routine clinical care
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 |
|---|---|---|
| BiofeedbackAlso: Video biofeedbackBiofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy. | Behavioural | Biofeedback |
| Laryngeal control therapy (LCT)Also: respiratory retrainingThis treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques. | Behavioural | Laryngeal control therapy |
Primary outcome
Dyspnea Index (DI)
Time frame: pre and 1 month post treatment
This is a 10-item questionnaire with scores that range from 0-40, with 40 representing the greatest possible severity of symptoms. The DI is a clinical assessment tool that was designed and validated specifically for patients with upper airway obstruction, including patients with PVFM. The primary outcome measure will be the difference between the two groups in the change in Dyspnea Index (DI).
4 secondary outcomes
Dyspnea Index (DI)
Time frame: pre and 3 months post treatment
Responder rates
Time frame: 1 month and 3 months post treatment
The Clinical Global Impressions - Improvement (CGI-I)
Time frame: 1 month and 3 months post treatment
Qualitative Survey
Time frame: 3 months post treatment
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 22 Dec 2025.
- Background: PubMed 30956693George S, Suresh S. Vocal Cord Dysfunction: Analysis of 27 Cases and Updated Review of Pathophysiology & Management. Int Arch Otorhinolaryngol. 2019 Apr;23(2):125-130. doi: 10.1055/s-0038-1661358. Epub 2018 Oct 24.
- Background: PubMed 27861929Kramer S, deSilva B, Forrest LA, Matrka L. Does treatment of paradoxical vocal fold movement disorder decrease asthma medication use? Laryngoscope. 2017 Jul;127(7):1531-1537. doi: 10.1002/lary.26416. Epub 2016 Nov 15.
- Background: PubMed 25152871Guglani L, Atkinson S, Hosanagar A, Guglani L. A systematic review of psychological interventions for adult and pediatric patients with vocal cord dysfunction. Front Pediatr. 2014 Aug 8;2:82. doi: 10.3389/fped.2014.00082. eCollection 2014.
- Background: PubMed 34699093Mahoney J, Hew M, Vertigan A, Oates J. Treatment effectiveness for Vocal Cord Dysfunction in adults and adolescents: A systematic review. Clin Exp Allergy. 2022 Mar;52(3):387-404. doi: 10.1111/cea.14036. Epub 2021 Nov 4.
- Background: PubMed 29631737Shaffer M, Litts JK, Nauman E, Haines J. Speech-Language Pathology as a Primary Treatment for Exercise-Induced Laryngeal Obstruction. Immunol Allergy Clin North Am. 2018 May;38(2):293-302. doi: 10.1016/j.iac.2018.01.003. Epub 2018 Mar 2.
- 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.
- Background: PubMed 25311596Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
- Background: PubMed 33602342LeBlanc RA, Aalto D, Jeffery CC. Visual biofeedback for paradoxical vocal fold motion (PVFM). J Otolaryngol Head Neck Surg. 2021 Feb 18;50(1):13. doi: 10.1186/s40463-021-00495-0.
- Background: PubMed 25104182De Guzman V, Ballif CL, Maurer R, Hartnick CJ, Raol N. Validation of the dyspnea index in adolescents with exercise-induced paradoxical vocal fold motion. JAMA Otolaryngol Head Neck Surg. 2014 Sep;140(9):823-8. doi: 10.1001/jamaoto.2014.1405.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Derived from this study: PubMed 41379457Strober WA, Rohlfing ML, Cutchin GM, Kallogjeri D, Piccirillo JF, Huston MN. Biofeedback vs Respiratory Retraining for Inducible Laryngeal Obstruction: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Feb 1;152(2):182-190. doi: 10.1001/jamaoto.2025.4542.
- Individual participant dataSharing planned: No
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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.
Margaret Huston, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Paradoxical Vocal Fold Motion and Vocal Cord Dysfunction, run by Washington University School of Medicine 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 4 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 22 Dec 2025. 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?
Dyspnea Index (DI) (time frame: pre and 1 month post treatment). 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 NCT05770518, which also lists 11 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 22 Dec 2025.