Prospective PI-Initiated Study of Nasal Dilator Therapy in Patulous Eustachian Tube Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Internal Nasal Dilator
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.
干预措施: Internal nasal dilator (Device)
结局指标
主要结局
Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
时间窗: 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.
次要结局
- 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)
研究者
Vrabec, Jeffrey M.D.
Professor of Otolaryngology-Head and Neck Surgery
The Methodist Hospital Research Institute