Assessing Mechanical Nasal Obstruction, a Potential New Treatment Option.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Peak Nasal Inspiratory Flow (PNIF)
研究概览
简要总结
The research team has developed a prototype for an investigational mechanical nasal dilator and the investigators aim to evaluate its efficacy.
Specifically, the investigators wish to address the following research questions: 1) How does mechanical nasal obstruction affect patients' lives? The investigators aim to answer this question with use of validated questionnaires. 2) How do currently available mechanical nasal dilators affect objective and subjective findings related to nasal obstruction? This will be evaluated with objective nasal airflow testing and with modifications to validated questionnaires 3) How does the investigational team's novel device affect these same outcome measures? 4) Do patients find the investigational device subjectively comfortable and efficient?
详细描述
Background:
Restricted nasal breathing is a common complaint among patients presenting to Otolaryngology clinics. In fact, one in eight people experiences some degree of nasal obstruction, or regular difficulty breathing through the nose, which is often the result of a narrowing or collapse of the internal nasal valve. This condition is a daily source of discomfort that reduces productivity and quality of life. Sufferers report shortness of breath throughout the day, difficulty sleeping and habitual snoring, and limited stamina during sports and exercise.
Slight dilation of the nasal passages directly counteracts nasal obstruction and reverses symptoms in 89% of those afflicted. To this end, many patients undergo functional rhinoplasty procedures to surgically widen the nasal passages. However, up to 20% of patients experience unimproved or worsened symptoms postoperatively. Moreover, these surgeries are invasive, requiring autologous grafts taken from the nose, ear, or ribs; and surgeries entail a yearlong recovery period.
Nasal dilators such as Breathe Right strips offer a potential alternative to surgery, as these dilators mechanically expand the nasal passages to effectively relieve obstruction. However, existing products are designed as sleep aids, and customers find them uncomfortable, difficult to use, and too visible to wear in public. Although the mechanism for reversing nasal obstruction is straightforward, surgery is considered the only viable option for those who struggle to breathe during the day.
Engineers from the Johns Hopkins Biomedical Engineering Department, partnered with clinicians from the Johns Hopkins Department of Otolaryngology - Head and Neck Surgery, have developed the Schnozzle, a small silicone stent to counteract nasal valve collapse and relieve restricted nasal breathing. The investigators hypothesize that this device will improve symptoms of nasal obstruction and provide patients with a viable alternative to visible non-invasive devices or surgical management. The aim of this study is to evaluate the feasibility and comfort of this device in comparison to existing commercially available devices.
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
盲法说明
Participants will be unaware of which nasal dilator they are trialing.
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
- •Patients who have presented to Otolaryngology clinics with complaints of nasal obstruction.
- •Patients who have been found to have nasal valve collapse by an Otolaryngologist based on performance of the Cottle maneuver will be invited to participate in the study.
- •Patients without evidence of nasal valve collapse, but are willing to participate in the study.
排除标准
- •History of granulomatosis with polyangiitis, extensive prior sinus or turbinate surgery altering nasal cavity anatomy, pre-existing nasal mucosal injuries or abnormalities
结局指标
主要结局
Change in Peak Nasal Inspiratory Flow (PNIF)
时间窗: Prior to device and after fitting each device (Up to 5 minutes)
PNIF will be measured using a PNIF meter. PNIF will be measured without any device in place and once during the fitting of each device. Flow is measured in liters per minute. Minimum value of -50, maximum value of 150 with higher scores indicating improved airflow.
次要结局
- Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE)(24-hour after trial of each device)
- Device Preference(Up to 5 days)
