Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score
研究概览
简要总结
This study was originally designed with three aims: (1) healthy controls to assess nasal nitric oxide, (2) adults with Eustachian Tube Dysfunction (ETD), and (3) adults with facial pain/pressure. However, only the ETD cohort (Aim 2) was initiated and enrolled. During study conduct, additional symptom and pain assessments (including MPQ-SF and mBPI-sf) were collected in the ETD cohort for exploratory purposes. All results in this record reflect ETD cohort participants who used the SinuSonic device twice daily for 6 weeks.
详细描述
The original protocol included three planned cohorts:
- Aim 1 - healthy controls for exhaled nasal nitric oxide (NO) testing;
- Aim 2 - adults with Eustachian Tube Dysfunction (ETD) to evaluate safety and efficacy;
- Aim 3 - adults with facial pain/pressure.
Only Aim 2 (ETD cohort) was opened to enrollment. Aims 1 and 3 were not initiated, and no participants were enrolled in those cohorts.
During study conduct, several patient-reported outcome measures originally associated with Aim 3 (MPQ-SF and mBPI-sf) were also administered to the ETD cohort for exploratory symptom profiling. Therefore, the Results section includes ETD-specific measures (ETDQ-7, ETD Symptom VAS, tympanogram) as well as pain-related measures for participants enrolled in the ETD cohort. All analyses derive exclusively from the ETD cohort participants (N=29 with baseline data).
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
- 是
入选标准
- •Inclusion Criteria:
- •Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
排除标准
- •Sinonasal or ear surgery within last 3 months (including balloon ET dilation)
- •Any ENT condition that may impact upper airway to include sinusitis, otitis, or allergies
- •Upper respiratory illness within last 2 weeks
- •Topical decongestant use in last week
- •Current nasal crusting or ulceration on rhinoscopy
- •History of severe nose bleeding within last 3 months
- •Known pregnancy
- •Allergic sensitivity to silicone or any other component of device
- •Inability to read and understand English
- •Inability to perform treatment due to underlying medical condition
- •Adults 18 years or older with diagnosis of ETD by an otolaryngologist
- •≥6 months of symptoms duration
- •≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of ears, muffled hearing, tinnitus)
- •ETDQ-7 score ≥ 3
- •Audiogram within the last year
- •Sinonasal or ear surgery within last 3 months (including balloon ET dilation)
- •Indwelling ear tubes
- •Tympanic membrane perforation
- •Hx of cholesteatoma, mastoidectomy, tympanoplasty, or ossicular chain reconstruction
- •Patulous ET
- •Hx of Meniere's disease
- •Moderate or severe nasal valve collapse
- •Grade 3-4 polyps
- •Upper respiratory illness within last 2 weeks
- •Topical decongestant use in last week
- •Current nasal crusting or ulceration on rhinoscopy
- •History of severe nose bleeding within last 3 months
- •Known pregnancy
- •Allergic sensitivity to silicone or any other component of device
- •Inability to read and understand English
- •Inability to perform treatment due to underlying medical condition
- •Adults 18 years or older who complain of facial pain or pressure
- •≥3 months of symptoms duration (can be intermittent)
- •Pain/pressure VAS score ≥ 5
- •Sinonasal surgery within the last 3 months
- •Grade 3-4 polyps
- •Upper respiratory illness within last 2 weeks
- •Topical decongestant use in last week
- •Current nasal crusting or ulceration on rhinoscopy
- •History of severe nose bleeding within last 3 months
- •Known pregnancy
- •Allergic sensitivity to silicone or any other component of device
- •Inability to read and understand English
- •Inability to perform treatment due to underlying medical condition
研究组 & 干预措施
SinuSonic Device
Participants used the SinuSonic device twice daily for 3 minutes in the home setting for 6 weeks. Baseline and 6-week assessments included ETDQ-7, ETD Symptom VAS, and tympanogram. Additional symptom and pain measures (MPQ-SF, mBPI-sf) were collected for exploratory purposes in this cohort.
干预措施: SinuSonic Device (Device)
结局指标
主要结局
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score
时间窗: 6 weeks (baseline to 6-week follow-up)
Five ETD symptoms (ear pressure, ear clogging, cracking/popping, muffled hearing, tinnitus) are each rated on a 10-cm line from 0 = "Not troublesome" to 10 = "Worst thinkable/troublesome." The total score is the sum of all five items (range 0-60). Higher scores indicate worse symptoms.
次要结局
- McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score(4 weeks)
- Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain(4 weeks)
研究者
Shaun A. Nguyen, MD
Professor
Medical University of South Carolina