Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
25 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Stephanie Camey, BA
- Telefoonnummer: 8327068834
- E-mail: scamey@houstonmethodist.org
Studie Contact Back-up
- Naam: Roger Neuberger, BS
- Telefoonnummer: 361-945-1327
- E-mail: rneuberger@houstonmethodist.org
Studie Locaties
-
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Werving
- Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
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Contact:
- Stephanie Camey, BA
- Telefoonnummer: 8327068834
- E-mail: scamey@houstonmethodist.org
-
Contact:
- Roger Neuberger, BS
- Telefoonnummer: 361-945-1327
- E-mail: rneuberger@houstonmethodist.org
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Hoofdonderzoeker:
- Jeffrey Vrabec, MD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acute change in PHI-10 score after first device application
Tijdsspanne: 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
|
|
Adherence to device wear
Tijdsspanne: Baseline through 3 to 4 weeks
|
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
|
|
Device usability and acceptability
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Number of participants with device-related adverse events
Tijdsspanne: 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.
|
Baseline through 3 to 4 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Jeffrey Vrabec, MD, The Methodist Hospital Research Institute
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 april 2026
Primaire voltooiing (Geschat)
1 november 2026
Studie voltooiing (Geschat)
22 april 2027
Studieregistratiedata
Eerst ingediend
25 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
25 augustus 2026
Eerst geplaatst (Werkelijk)
31 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
25 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- PRO00042612
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared.
This is a single-site pilot study; data will be reported in aggregate form only.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .