NCT07796139 Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
| NCT ID | NCT07796139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Patulous Eustachian Tube Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-04-22 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Jeffrey Vrabec, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT07796139 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patulous Eustachian Tube Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07796139 currently recruiting?
Yes, NCT07796139 is actively recruiting participants. Contact the research team at scamey@houstonmethodist.org for enrollment information.
Where is the NCT07796139 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07796139 clinical trial?
NCT07796139 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Jeffrey Vrabec, MD at The Methodist Hospital Research Institute. The trial plans to enroll 50 participants.