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NCT Number: NCT07796139

Nasal Dilator Therapy for 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.

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Key information

Conditions

Patulous Eustachian Tube Dysfunction Eustachian Tube Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77030, United States

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Airmax Nasal Dilator

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Prospective PI-Initiated Study of Nasal Dilator Therapy in Patulous Eustachian Tube Dysfunction

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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