EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
This study evaluates the use of the EarFlo device in adults with clinically confirmed Eustachian tube dysfunction and/or otitis media with effusion. The purpose of the study is to assess the safety, tolerability, and short-term effects of device use on ear pressure symptoms and middle ear function.
Participants will complete a brief symptom questionnaire, undergo routine ear examinations and testing, and use the EarFlo device once during a clinic visit. Ear examination and testing will be repeated after device use to evaluate any short-term changes. This study involves a single study visit and does not include any surgical or invasive procedures.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Otitis media with effusion (OME) is a condition characterized by the presence of fluid in the middle ear and may occur in both children and adults. Eustachian tube dysfunction (ETD) is commonly associated with OME and may contribute to symptoms such as ear fullness, pressure, muffled hearing, and discomfort due to impaired ventilation of the middle ear.
The EarFlo device is designed to promote Eustachian tube opening during swallowing. The EarFlo device has been previously evaluated in pediatric populations with otitis media with effusion and is FDA-cleared for its intended use.This study aims to evaluate the safety, tolerability, and short-term effects of the EarFlo device in an adult population diagnosed with OME and/or ETD.
This is a prospective, single-visit, non-randomized interventional study evaluating the safety, tolerability, and short-term effects of the EarFlo device in adults with otitis media with effusion (OME) and/or Eustachian tube dysfunction (ETD). The study focuses on short-term changes in subjective symptoms and objective middle ear findings following a single supervised use of the device in a clinical setting.
Eligible participants will attend one study visit. At baseline, participants will complete a validated symptom questionnaire and undergo routine otologic evaluation, including otoscopic examination and tympanometry, as clinically appropriate. Otoscopic images of the tympanic membrane and middle ear will be captured prior to device use.
Participants will then receive instruction on proper use of the EarFlo device from trained study personnel. The device will be used once during the visit while the participant drinks a liquid of their choice. Device use is noninvasive and does not involve surgical procedures or sedation.
Following device use, participants will repeat middle ear assessments, including tympanometry and otoscopic examination. Post-use otoscopic images will be captured and compared with baseline images. Otoscopic images will be reviewed and categorized as improved or not improved by a physician who is blinded to the timing of image acquisition (pre- or post-device use).
The primary objectives of this study are to evaluate the safety, tolerability, and short-term effects of the EarFlo device in adults and to obtain preliminary estimates of its short-term effects on ear pressure symptoms and middle ear findings following a single supervised use. As a single-arm pilot study, the findings are intended to inform the design of future controlled studies. No long-term follow-up is required.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Zarna P Lalwani, BDS, MPH
- Sähköposti: zpl5@pitt.edu
Opiskelupaikat
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Pennsylvania
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Pittsburgh, Pennsylvania, Yhdysvallat, 15219
- UPMC Mercy
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Pittsburgh, Pennsylvania, Yhdysvallat, 15232
- UPMC Shadyside
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Pittsburgh, Pennsylvania, Yhdysvallat, 15213
- UPMC Montefiore
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Pittsburgh, Pennsylvania, Yhdysvallat, 15213
- Eye and Ear Institute / UPMC Presbyterian
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Adults aged 18 years and older.
- Adults with confirmed Otitis Media with Effusion (OME) diagnosis with clinical assessment.
- Adults with confirmed dilatory ETD (Eustachian Tube Dysfunction) on clinical assessment.
- Willingness to refrain from initiating new treatments for OME/ETD (e.g., new surgical or device treatments, tympanostomy tubes) during the study period. Standard care will not be refrained if needed.
Exclusion Criteria:
- Presence of acute otitis media, ear infection, or otorrhea within the past 4 weeks.
- Any medical, psychiatric, or cognitive condition that, in the opinion of the investigators, would interfere with study participation or compliance.
- Inability to use the EarFlo device as instructed (e.g., due to severe nasal obstruction, craniofacial anomalies, or neuromuscular disorders).
- Recent eye, ear or nose surgeries or ear trauma. (<4 weeks)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: EarFlo Intervention Arm
Participants in this single arm will undergo baseline assessments, use the EarFlo device once during a clinic visit, and complete post-use assessments to evaluate short-term changes in ear symptoms and middle ear function.
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The EarFlo device is a non-invasive, cup-based device used during swallowing to help equalize middle ear pressure.
By delivering a controlled puff of air through the nose during swallowing, it assists Eustachian tube opening to relieve negative middle ear pressure.
Participants will use the device once during a single clinic visit while drinking water or a beverage of their choice.
No surgery or invasive procedures are involved.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device
Aikaikkuna: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
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Change in middle ear pressure measured using tympanometric peak pressure (daPa) immediately before and immediately after a single supervised in-clinic use of the EarFlo device.
Tympanometric peak pressure values will be compared to evaluate short-term changes in middle ear function.
More positive values indicate improved middle ear pressure equalization.
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Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
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Blinded otoscopic image assessment of middle ear effusion before and after EarFlo device use
Aikaikkuna: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
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Otoscopic images obtained immediately before and immediately after EarFlo device use will be independently reviewed by a blinded physician.
Images will be classified as improved or not improved based on predefined evidence of middle ear effusion and tympanic membrane appearance.
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Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Incidence, severity, and relatedness of adverse events
Aikaikkuna: From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.
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Safety and tolerability of the EarFlo device in Adults will be assessed based on the number and percentage of participants experiencing adverse events.
Adverse events will be summarized according to incidence, severity, and relationship to the EarFlo device or study procedure.
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From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Philip L Perez, MD, University of Pittsburgh
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY25050186
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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