Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07796139
Status
Recruiting
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Conditions

  • Eustachian Tube Dysfunction
  • Patulous Eustachian Tube Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Internal nasal dilator — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Apr 22, 2026
Status verified
Aug 2026
Primary completion
Nov 1, 2026
Completion
Apr 22, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score [ Time Frame: Baseline and 3 to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Hospital - Department of Otolaryngology-Head & Neck SurgeryHoustonTexas77030
Stephanie Camey, BA
[email protected]
8327068834
Roger Neuberger, BS
[email protected]
361-945-1327
Jeffrey Vrabec, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery· Houston, TX

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