Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction

August 25, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Vrabec, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Internal nasal dilator
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.
Other Names:
  • Airmax Nasal Dilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute change in PHI-10 score after first device application
Time Frame: 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.
Baseline and 10 minutes after first application
Adherence to device wear
Time Frame: 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.
Baseline through 3 to 4 weeks
Device usability and acceptability
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Jeffrey Vrabec, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

April 22, 2027

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO00042612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. This is a single-site pilot study; data will be reported in aggregate form only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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