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.
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Stephanie Camey, BA
- 전화번호: 8327068834
- 이메일: scamey@houstonmethodist.org
연구 연락처 백업
- 이름: Roger Neuberger, BS
- 전화번호: 361-945-1327
- 이메일: rneuberger@houstonmethodist.org
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- 모병
- Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery
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연락하다:
- Stephanie Camey, BA
- 전화번호: 8327068834
- 이메일: scamey@houstonmethodist.org
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연락하다:
- Roger Neuberger, BS
- 전화번호: 361-945-1327
- 이메일: rneuberger@houstonmethodist.org
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수석 연구원:
- Jeffrey Vrabec, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score
기간: Baseline and 3 to 4 weeks
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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.
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Baseline and 3 to 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Acute change in PHI-10 score after first device application
기간: Baseline and 10 minutes after first application
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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.
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Baseline and 10 minutes after first application
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Adherence to device wear
기간: Baseline through 3 to 4 weeks
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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.
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Baseline through 3 to 4 weeks
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Device usability and acceptability
기간: 3 to 4 weeks
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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.
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3 to 4 weeks
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Global Rating of Change
기간: 3 to 4 weeks
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Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit.
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3 to 4 weeks
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Number of participants with device-related adverse events
기간: Baseline through 3 to 4 weeks
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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.
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Baseline through 3 to 4 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeffrey Vrabec, MD, The Methodist Hospital Research Institute
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PRO00042612
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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