Patulous Eustachian Tube DysfunctionNCT07796139
Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
A study testing Internal nasal dilator in people with Patulous Eustachian Tube Dysfunction and Eustachian Tube Dysfunction, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patulous Eustachian Tube Dysfunction, Eustachian Tube Dysfunction
- What is being tested?
- Internal nasal dilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Non-English speaking, as the PHI-10 and study materials are currently available only in English
- Pregnant
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
Houston, Texas, 77030
Stephanie Camey, BA, 8327068834, scamey@houstonmethodist.org
Roger Neuberger, BS, 361-945-1327, rneuberger@houstonmethodist.org
About this study
Official title: Prospective PI-Initiated Study of Nasal Dilator Therapy in 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.
Read more
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.
Read the 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).
- Being tested
- Internal nasal dilator
- Keywords
- patulous eustachian tube, PET, nasal dilator, Cottle maneuver, autophony, PHI-10, nasal valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal nasal dilatorDevice
Also called Airmax 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Internal nasal dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 to 4 weeks
Secondary outcomes (5)
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.
Measured: Baseline and 10 minutes after first application
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.
Measured: Baseline through 3 to 4 weeks
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.
Measured: 3 to 4 weeks
Global Rating of Change
Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit.
Measured: 3 to 4 weeks
Number of participants with device-related adverse events
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.
Measured: Baseline through 3 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start22 Apr 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patulous Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vrabec, Jeffrey M.D., The Methodist Hospital Research Institute
- Investigators
- Jeffrey Vrabec, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796139
- Sponsor's protocol ID
- PRO00042612
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared. This is a single-site pilot study; data will be reported in aggregate form only.
Publications
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.
PubMed 27063750Mehta 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.
PubMed 34606099Luu 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.
PubMed 26595716
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective PI-Initiated Study of Nasal Dilator Therapy in Patulous Eustachian Tube Dysfunction
- ClinicalTrials.gov ID
- NCT07796139
- Acronym / sponsor ID
- PRO00042612
- Keywords
- patulous eustachian tube, PET, nasal dilator, Cottle maneuver, autophony, PHI-10, nasal valve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internal Nasal Dilator | Experimental | Device: Internal nasal dilatorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal nasal dilatorAlso: Airmax Nasal DilatorSingle-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. | Device | Internal Nasal Dilator |
Primary outcome
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.
5 secondary outcomes
Acute change in PHI-10 score after first device application
Time frame: Baseline and 10 minutes after first application
Adherence to device wear
Time frame: Baseline through 3 to 4 weeks
Device usability and acceptability
Time frame: 3 to 4 weeks
Global Rating of Change
Time frame: 3 to 4 weeks
Number of participants with device-related adverse events
Time frame: Baseline through 3 to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 27063750Dinardi 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.
- Background: PubMed 34606099Mehta 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.
- Background: PubMed 26595716Luu 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This is a single-site pilot study; data will be reported in aggregate form only.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Vrabec, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal nasal dilator in people with Patulous Eustachian Tube Dysfunction and Eustachian Tube Dysfunction, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Camey, BA (8327068834, scamey@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score (time frame: Baseline and 3 to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07796139, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.