Recruiting

Nasal Dilator

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT07796139

Conditions

Patulous Eustachian Tube Dysfunction

Eustachian Tube Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internal nasal dilator

Study Details

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.

Conditions

Patulous Eustachian Tube Dysfunction

Eustachian Tube Dysfunction

Study ID

NCT07796139

Start date

Apr 22, 2026

Status verified date

Aug, 2026

Completion date

Apr 22, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Jeffrey Vrabec, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • patulous eustachian tube
  • PET
  • nasal dilator
  • Cottle maneuver
  • autophony
  • PHI-10
  • nasal valve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-08-31.