Nasal Dilator Therapy for Patulous Eustachian Tube

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, prospective pilot study assessing a commercially available internal nasal dilator (Airmax) in adults with confirmed patulous Eustachian tube dysfunction and a positive Cottle maneuver. Symptoms are measured at baseline, 10 minutes after first use, and at a 3–4 week follow-up using the PHI-10 questionnaire. The goal is to estimate effect sizes to guide future controlled trials, with the device used off-the-shelf and no device modification. The study is exempt from IDE requirements under applicable FDA regulations and is conducted at a single Houston Methodist otolaryngology site.

Why it matters

Who can join: the full rules

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

Where it's running

• Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Jeffrey Vrabec, MD — The Methodist Hospital Research Institute
• Study coordinator: Stephanie Camey, BA
• Email: scamey@houstonmethodist.org
• Phone: 8327068834

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.