Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
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.
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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Stephanie Camey, BA
- 電話番号：8327068834
- メール：scamey@houstonmethodist.org
研究連絡先のバックアップ
- 名前：Roger Neuberger, BS
- 電話番号：361-945-1327
- メール：rneuberger@houstonmethodist.org
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- 募集
- Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
-
コンタクト：
- Stephanie Camey, BA
- 電話番号：8327068834
- メール：scamey@houstonmethodist.org
-
コンタクト：
- Roger Neuberger, BS
- 電話番号：361-945-1327
- メール：rneuberger@houstonmethodist.org
-
主任研究者：
- Jeffrey Vrabec, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
時間枠：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.
|
Baseline and 3 to 4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute change in PHI-10 score after first device application
時間枠：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.
|
Baseline and 10 minutes after first application
|
|
Adherence to device wear
時間枠：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.
|
Baseline through 3 to 4 weeks
|
|
Device usability and acceptability
時間枠：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.
|
3 to 4 weeks
|
|
Global Rating of Change
時間枠：3 to 4 weeks
|
Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit.
|
3 to 4 weeks
|
|
Number of participants with device-related adverse events
時間枠：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.
|
Baseline through 3 to 4 weeks
|
協力者と研究者
捜査官
- 主任研究者：Jeffrey Vrabec, MD、The Methodist Hospital Research Institute
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PRO00042612
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。