Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
25. august 2026 oppdatert av: Vrabec, Jeffrey M.D., The Methodist Hospital Research Institute
Prospective PI-Initiated Study of Nasal Dilator Therapy in Patulous Eustachian Tube Dysfunction
The Eustachian tube connects the middle ear to the back of the nose and throat, providing ventilation of the middle ear. People with a patulous Eustachian tube perceive the tube stays open continuously. This can make a person's own voice and breathing sound unusually loud in the ear and can cause a feeling of fullness or blocked hearing. There is currently no agreed-upon first treatment for these symptoms.
Some people with this condition notice their symptoms improve when they gently pull the cheek outward to widen the nasal passage. A nasal dilator is a small, soft device worn just inside the nostrils that does something similar by holding the nasal passage more open. Nasal dilators are sold over the counter and are commonly used for stuffy nose and snoring. They have not been studied as a treatment for patulous Eustachian tube.
This study will look at whether wearing a nasal dilator reduces symptoms in adults with patulous Eustachian tube. About 50 adults treated at Houston Methodist will take part. Everyone in the study receives the nasal dilator; there is no placebo or comparison group.
Participants complete a 10-question symptom survey before using the device, again 10 minutes after putting it in for the first time, and once more at a follow-up clinic visit about 3 to 4 weeks later. Between visits, participants wear the device at home and keep track of how often they use it. At the follow-up visit they also answer questions about whether the device was comfortable and easy to use, and whether they had any side effects. Participation lasts about 3 to 4 weeks.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
This is a single-arm, prospective, pre/post pilot study of a commercially available internal nasal dilator (Airmax) in adults with clinically confirmed patulous Eustachian tube dysfunction and a positive Cottle maneuver.
Symptom burden is measured with the Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) at baseline, 10 minutes after first device application, and at a 3-4 week follow-up visit.
The study is intended to generate effect-size estimates to inform the design of subsequent controlled trials.
The device is over-the-counter, 510(k)-exempt, used without modification, and the study is exempt from IDE requirements under 21 CFR 812.2(c).
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Stephanie Camey, BA
- Telefonnummer: 8327068834
- E-post: scamey@houstonmethodist.org
Studer Kontakt Backup
- Navn: Roger Neuberger, BS
- Telefonnummer: 361-945-1327
- E-post: rneuberger@houstonmethodist.org
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
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Ta kontakt med:
- Stephanie Camey, BA
- Telefonnummer: 8327068834
- E-post: scamey@houstonmethodist.org
-
Ta kontakt med:
- Roger Neuberger, BS
- Telefonnummer: 361-945-1327
- E-post: rneuberger@houstonmethodist.org
-
Hovedetterforsker:
- Jeffrey Vrabec, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adults aged 18 years or older
- Treated by a clinician in the Houston Methodist Department of Otolaryngology - Head and Neck Surgery
- Positive response to the Cottle maneuver
- Able and willing to provide informed consent
- Able to complete study surveys
- Willing to avoid starting new therapies directed at patulous Eustachian tube during the study window unless medically necessary
Exclusion Criteria:
- Active middle-ear disease at screening
- Significant nasal pathology precluding safe use of a nasal dilator
- Known intolerance or hypersensitivity to nasal dilators
- Any condition judged by the investigator to increase risk or confound assessments
- Unable to provide informed consent
- Cognitive impairment preventing completion of study surveys
- Non-English speaking, as the PHI-10 and study materials are currently available only in English
- Pregnant
- Prisoner
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Internal Nasal Dilator
Participants receive a commercially available internal nasal dilator (Airmax) at the baseline clinic visit, along with sizing, fitting, and hygiene instruction from trained study staff.
Participants apply the device during the visit and continue at-home use per the study wear schedule until the follow-up visit approximately 3 to 4 weeks later.
|
Single-patient-use, over-the-counter internal nasal dilator worn inside the nasal vestibule to laterally support the nasal valve and increase nasal cross-sectional area.
Devices are supplied in sealed retail packaging without modification.
Participants wear the device per the prescribed schedule from the baseline visit until the follow-up visit at 3 to 4 weeks.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
Tidsramme: Baseline and 3 to 4 weeks
|
The PHI-10 is a 10-item validated patient-reported instrument measuring symptom burden in patulous Eustachian tube.
Total scores range from 0 to 40, with lower scores indicating fewer symptoms.
The outcome is the change in total score from baseline to the follow-up visit.
|
Baseline and 3 to 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acute change in PHI-10 score after first device application
Tidsramme: Baseline and 10 minutes after first application
|
Change in PHI-10 total score from baseline to 10 minutes (±5 minutes) after the participant first applies the nasal dilator, assessing immediate symptom response.
Scores range 0 to 40; lower is better.
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Baseline and 10 minutes after first application
|
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Adherence to device wear
Tidsramme: Baseline through 3 to 4 weeks
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Self-reported average hours of device wear per day and percentage of prescribed days on which the device was worn, collected at the follow-up visit.
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Baseline through 3 to 4 weeks
|
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Device usability and acceptability
Tidsramme: 3 to 4 weeks
|
Participant ratings of comfort, ease of use, and willingness to continue use, each scored on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability.
|
3 to 4 weeks
|
|
Global Rating of Change
Tidsramme: 3 to 4 weeks
|
Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit.
|
3 to 4 weeks
|
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Number of participants with device-related adverse events
Tidsramme: Baseline through 3 to 4 weeks
|
Count of participants experiencing device-related adverse events, including nasal irritation, pressure discomfort, and epistaxis.
Assessed at first wear, at the follow-up visit, and by interim report between visits.
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Baseline through 3 to 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jeffrey Vrabec, MD, The Methodist Hospital Research Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Dinardi RR, de Andrade CR, Martins-Costa HC, Ibiapina Cda C. Does the Airmax(R) internal nasal dilator increase peak nasal inspiratory flow (PNIF) in adolescent athletes? Int J Pediatr Otorhinolaryngol. 2016 May;84:37-42. doi: 10.1016/j.ijporl.2016.02.023. Epub 2016 Feb 27.
- Mehta NK, Ma C, Nguyen SA, McRackan TR, Meyer TA, Lambert PR. Medical Management for Eustachian Tube Dysfunction in Adults: A Systematic Review and Meta-Analysis. Laryngoscope. 2022 Apr;132(4):849-856. doi: 10.1002/lary.29878. Epub 2021 Oct 4.
- Luu K, Remillard A, Fandino M, Saxby A, Westerberg BD. Treatment Effectiveness for Symptoms of Patulous Eustachian Tube: A Systematic Review. Otol Neurotol. 2015 Dec;36(10):1593-600. doi: 10.1097/MAO.0000000000000900.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. april 2026
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
22. april 2027
Datoer for studieregistrering
Først innsendt
25. august 2026
Først innsendt som oppfylte QC-kriteriene
25. august 2026
Først lagt ut (Faktiske)
31. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- PRO00042612
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared.
This is a single-site pilot study; data will be reported in aggregate form only.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .