Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion

NCT07420530 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 29009R01DC023381
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objectives of the proposed research are to:

1. 1.Evaluate the diagnostic validity of a novel mechano-acoustic signatures of task-characteristic activity during symptomatic and asymptomatic breathing in Exercise-Induced Laryngeal Obstruction (EILO) patients with the use of a novel miniature, soft wearable skin-mounted device,
2. 2.Identify the mechanism/s of paradoxical respiratory control in EILO by quantifying the relationship between pulmonary mechanics, partial pressure of carbon dioxide (PCO2) maintenance, and vocal fold aperture prior to and during symptomatic and asymptomatic exercise ventilation, and
3. 3.Identify unique biophysiological factors contributing to EILO among exercisers with and without EILO. Findings will be highly novel and clinically significant for early identification and management of EILO.
4. 4.Free running with the device on the neck
5. 5.Exercise treadmill study
6. 6.Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.

Conditions

Exercise-Induced Vocal Cord Dysfunction; Paradoxical Vocal Fold Motion; Vocal Cord Dysfunction

Outcome Measures

Primary Outcomes (11)

• Device measurements from real time running

  Muscle activation of cricothyroid/sternohyoid muscle measured via customized surface electromyography amplifier

  Baseline and Periprocedural

• Device measurements from real time running

  Normalized amplitude (100% of maximum voluntary contraction) Burst duration (milliseconds) prior to and during Exercise-Induced Laryngeal Obstruction event of laryngeal closure.

  Baseline and Periprocedural

• Device measurements from real time running

  Exercise-Induced Laryngeal Obstruction signature detected via ultra-low noise micro-electromechanical (MEMS) microphone amplitude (dB) prior to and during EILO. EILO signature detected via accelerometer (g, where g represents the gravitational acceleration of 9.8 m/s2) prior to and during EILO

  Baseline and Perioprocedural

• Treadmill testing

  Breathing frequency (breaths per minute)

  Baseline and Perioprocedural

• Treadmill testing

  Tidal volume (Liters)

  Base-line

• Treadmill testing

  Ventilation (Liters/minute)

  Breath-by-breath baseline and Perioprocedural

• Treadmill testing

  Partial pressure of arterial carbon dioxide estimated from end-tidal partial pressure of carbon dioxide; PetCO2) (mmHg)

  Baseline and Periprocedural

• MRI Upper Airway Size

  Length (mm), width (mm), and cross-sectional area (mm2) of oropharynx, supraglottis, glottis, immediate subglottis.

  Baseline

• Upper Airway Aerodynamics

  pressure (Pa) across oropharynx, supraglottis, and subglottis

  Baseline and Periprocedural

• Upper Airway Aerodynamics

  volume flow rate (l/s) across oropharynx, supraglottis, and subglottis

  Baseline and Periprocedural

• Upper Airway Aerodynamics

  flow velocities (m/s) across oropharynx, supraglottis, and subglottis

  Baseline and Periprocedural

Secondary Outcomes (1)

• Self-rating of dyspnea

  Baseline

Study Arms (3)

Control Arm

NO INTERVENTION

Participants will breathe room air

Experimental Arm

EXPERIMENTAL

Participants will breathe Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen)).

Drug: Carbon Dioxide

Breathing exercise

OTHER

Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Behavioral: Breathing treatment

Interventions

Breathing treatment BEHAVIORAL

Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Breathing exercise

Carbon Dioxide DRUG

Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active \>2.5 hours per week
• Patients with EILO, as diagnosed by routine clinical examination by physician and/or speech language pathologist
• Age range of 18-26 years
• Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise
• Score of 7 or higher on the Dyspnea Index, which is a validated instrument to capture participant self-report of upper airway dyspnea symptoms.
• Classified as low risk, based on the modified Physical Activity Readiness Questionnaire (PAR-Q) questionnaire, body mass index, and non-smoking status
• Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
• Physically active \>2.5 hours per week
• Age range of 18-26 years
• Classified as low risk, based on the modified PAR-Q questionnaire, body mass index, and non-smoking status
• Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

You may not qualify if:

• Individuals older than 26 years and younger than 18 years of age.
• Women who are pregnant or could possibly be pregnant.
• BMI \> 25 kg/m2
• A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
• Current smoker
• Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
• Do not report the following: Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise
• Individuals older than 26 years and younger than 18 years of age.
• Women who are pregnant or could possibly be pregnant.
• BMI \> 25 kg/m2
• A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
• Current smoker
• Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
• Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Sponsors & Collaborators

• Indiana University: lead
• Indiana University School of Medicine: collaborator
• Purdue University: collaborator
• National Jewish Health: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Indiana University

Bloomington, Indiana, 47401, United States

RECRUITING

MeSH Terms

Conditions

Vocal Cord Dysfunction

Interventions

Carbon Dioxide; Respiratory Therapy

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Therapeutics

Study Officials

• Rita Patel

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita R Patel

CONTACT

812-855-3886; patelrir@iu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel-group, single-blinded, randomized design Participants (Exercise-Induced Laryngeal Obstruction (EILO) and controls) will be stratified by group (EILO vs. Control) and then randomized 1:1 to either the room air or hypercapnic gas condition.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 19, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 20, 2032
• Study Completion (Estimated): January 20, 2032
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

US (1)