Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Internal nasal dilator
DeviceSingle-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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Internal Nasal DilatorExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 3 to 4 weeksSecondary outcomes
1
Acute change in PHI-10 score after first device 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.
Time frame
Baseline and 10 minutes after first application2
Adherence to device wear
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.
Time frame
Baseline through 3 to 4 weeks3
Device usability and acceptability
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.
Time frame
3 to 4 weeks4
Global Rating of Change
Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit.
Time frame
3 to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov