Eustachian Tube Dysfunction, Patulous Eustachian Tube Dysfunction
Conditions
Keywords
patulous eustachian tube, PET, nasal dilator, Cottle maneuver, autophony, PHI-10, nasal valve
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.
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).
Interventions
DEVICEInternal 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.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute change in PHI-10 score after first device application | 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. |
| Adherence to device wear | 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. |
| Device usability and acceptability | 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. |
| Global Rating of Change | 3 to 4 weeks | Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit. |
| Number of participants with device-related adverse events | 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. |
Countries
United States
Contacts
CONTACTStephanie Camey, BA
CONTACTRoger Neuberger, BS
PRINCIPAL_INVESTIGATORJeffrey Vrabec, MD
The Methodist Hospital Research Institute
Outcome results
None listed