Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction

NCT07796139 | Recruiting FDA Device

• 1 other identifier: PRO00042612
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score

  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 Outcomes (5)

• Acute change in PHI-10 score after first device application

  Baseline and 10 minutes after first application

• Adherence to device wear

  Baseline through 3 to 4 weeks

• Device usability and acceptability

  3 to 4 weeks

• Global Rating of Change

  3 to 4 weeks

• Number of participants with device-related adverse events

  Baseline through 3 to 4 weeks

Study Arms (1)

Internal Nasal Dilator

EXPERIMENTAL

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

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.

Also known as: Airmax Nasal Dilator

Internal Nasal Dilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

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

Houston, Texas, 77030, United States

RECRUITING

Related Publications (3)

• Dinardi RR, de Andrade CR, Martins-Costa HC, Ibiapina Cda C. Does the Airmax(R) internal nasal dilator increase peak nasal inspiratory flow (PNIF) in adolescent athletes? Int J Pediatr Otorhinolaryngol. 2016 May;84:37-42. doi: 10.1016/j.ijporl.2016.02.023. Epub 2016 Feb 27.

  PMID: 27063750 BACKGROUND

• Mehta NK, Ma C, Nguyen SA, McRackan TR, Meyer TA, Lambert PR. Medical Management for Eustachian Tube Dysfunction in Adults: A Systematic Review and Meta-Analysis. Laryngoscope. 2022 Apr;132(4):849-856. doi: 10.1002/lary.29878. Epub 2021 Oct 4.

  PMID: 34606099 BACKGROUND

• Luu K, Remillard A, Fandino M, Saxby A, Westerberg BD. Treatment Effectiveness for Symptoms of Patulous Eustachian Tube: A Systematic Review. Otol Neurotol. 2015 Dec;36(10):1593-600. doi: 10.1097/MAO.0000000000000900.

  PMID: 26595716 BACKGROUND

Study Officials

• Jeffrey Vrabec, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Camey, BA

CONTACT

8327068834; scamey@houstonmethodist.org

Roger Neuberger, BS

CONTACT

361-945-1327; rneuberger@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 31, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 22, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)