Hengityksen ja reaaliaikaisen dynamiikan yhteydet liikuntaa aiheuttavassa paradoksaalisessa äänihuuliliikkeessä (EILO)
Respiratoriset ja reaaliaikaiset dynamiikat liikunnan aiheuttamassa paradoksaalisessa äänihuuliliikkeessä
The overall objectives of the proposed research are to:
- 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,
- 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
- 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.
The main study will enroll 60 participants with EILO and 60 without EILO to complete three separate visits:
- Exercise treadmill study
- Free running with the device on the neck
- Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Main Study
At the first study visit, participants will sign informed consent, complete study questionnaires, have their height, weight, and body composition measured, and perform resting pulmonary function tests. Participants will then warm up on the treadmill for 10 minutes. An endoscope will be placed in one nostril until the vocal folds are visible, and subjects will be fitted with a chest strap heart rate monitor, an oro-nasal face mask, and the mechanoacoustic device. This sensor is placed on the neck with a velcro band. Participants will then undergo a graded exercise test during which a carbon-dioxide enriched gas mixture will be administered. The amount of the gas mixture will be titrated based on measures of the participant's breathing and lung function. This visit will be video recorded.
At the second study visit, participants will be asked to again wear the mechanoacoustic device while free running for 10 minutes in a large room or on a track. This visit will be video-recorded.
At the third study visit, participants will be asked to undergo an MRI scan, during which they will perform a variety of breathing exercises including rest breathing, rapid breathing, pursed lip breathing, sniff, and open mouth breathing. Research personnel will instruct participants in the various breathing techniques prior to the scan.
The study visits may occur in any order.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Rita R Patel
- Puhelinnumero: 812-855-3886
- Sähköposti: patelrir@iu.edu
Opiskelupaikat
-
-
Indiana
-
Bloomington, Indiana, Yhdysvallat, 47401
- Rekrytointi
- Indiana University
-
Ottaa yhteyttä:
- Rita Patel
- Puhelinnumero: 812-855-3886
- Sähköposti: patelrir@iu.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria for Exercise-Induced Laryngeal Obstruction (EILO):
- 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.
Inclusion Criteria for Controls
- 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.
Exclusion Criteria for EILO:
- Individuals older than 26 years and younger than 18 years of age.
- Women who are pregnant or could possibly be pregnant.
- 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
Exclusion Criteria for Controls
- Individuals older than 26 years and younger than 18 years of age.
- Women who are pregnant or could possibly be pregnant.
- 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.
- Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Active Comparator: EILO Participants
|
Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen)) A custom developed mechanoacoustic sensor will be worn on the neck using a Velcro strap. The device will collect audio recordings of breathing and breath sounds and will collect muscle activity from the neck muscles. |
|
Active Comparator: Control Participants
Participants without Exercise-induced laryngeal obstruction (EILO). |
Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen)) A custom developed mechanoacoustic sensor will be worn on the neck using a Velcro strap. The device will collect audio recordings of breathing and breath sounds and will collect muscle activity from the neck muscles. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Device measurements from real time running
Aikaikkuna: Baseline and Periprocedural
|
Muscle activation of cricothyroid/sternohyoid muscle measured via customized surface electromyography amplifier |
Baseline and Periprocedural
|
|
Device measurements from real time running
Aikaikkuna: Baseline and Periprocedural
|
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
Aikaikkuna: Baseline and Perioprocedural
|
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
Aikaikkuna: Baseline and Perioprocedural
|
Breathing frequency (breaths per minute) |
Baseline and Perioprocedural
|
|
Treadmill testing
Aikaikkuna: Baseline
|
Tidal volume (Liters) |
Baseline
|
|
Treadmill testing
Aikaikkuna: Breath-by-breath baseline and Perioprocedural
|
Ventilation (Liters/minute) |
Breath-by-breath baseline and Perioprocedural
|
|
Treadmill testing
Aikaikkuna: Baseline and Periprocedural
|
Partial pressure of arterial carbon dioxide estimated from end-tidal partial pressure of carbon dioxide; PetCO2) (mmHg) |
Baseline and Periprocedural
|
|
MRI Upper Airway Size
Aikaikkuna: Baseline
|
Length (mm), width (mm), and cross-sectional area (mm2) of oropharynx, supraglottis, glottis, immediate subglottis. |
Baseline
|
|
Upper Airway Aerodynamics
Aikaikkuna: Baseline and Periprocedural
|
pressure (Pa) across oropharynx, supraglottis, and subglottis |
Baseline and Periprocedural
|
|
Upper Airway Aerodynamics
Aikaikkuna: Baseline and Periprocedural
|
volume flow rate (l/s) across oropharynx, supraglottis, and subglottis |
Baseline and Periprocedural
|
|
Upper Airway Aerodynamics
Aikaikkuna: Baseline and Periprocedural
|
flow velocities (m/s) across oropharynx, supraglottis, and subglottis |
Baseline and Periprocedural
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Self-rating of dyspnea
Aikaikkuna: Baseline
|
Participants will rate breathing intensity and breathing unpleasantness on a Visual Analog Scale of 0 to 100mm, where 0 indicates not at all and 100 indicates maximal imaginable intensity/unpleasantness. |
Baseline
|
|
Profile of Mood States (POMS)
Aikaikkuna: Baseline
|
The POMS will be used to evaluate the participants' mood and to better understand how the emotional state relates to physical responses during testing. The POMS measures different aspects of mood on a 5-point Likert scale from 0 (not at all) to 4 (extremely). |
Baseline
|
|
Menstrual Screening Questionnaire
Aikaikkuna: Baseline
|
Female participants will complete a screening questionnaire about menstruation history and use of hormonal birth control which will be used to evaluate the relationship between EILO and menstruation. |
Baseline
|
|
Pittsburgh Sleep Quality Index (PSQI)
Aikaikkuna: Baseline
|
The PSQI will be used to evaluate the relationship between sleep and exercise. Total PSQI scores range from 0 to 21 with lower scores indicating better sleep quality. |
Baseline
|
|
International Physical Activity Questionnaire (IPAQ)
Aikaikkuna: Baseline
|
Participants will complete the IPAQ which collects information on the frequency and duration of physical activities. |
Baseline
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Yhteistyökumppanit
Yhteistyökumppanit
Tutkijat
Tutkijat
- Päätutkija: Rita Patel, Indiana University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 29009
- R01DC023381 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
The data will be available indefinitely, as per NIH's Data Management and Sharing Policy to maximize the appropriate sharing of scientific data.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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