NCT02136043已完成不适用
A Randomized Study (With Active Treatment in Both Treatment Groups) to Evaluate How a New Vibration Treatment in the Nose in Patients With Non-allergic Rhinitis Can be Done as Convenient as Possible to the Patient
Halmstad County Hospital1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Pain score on the Visual Analogue Scale
研究概览
简要总结
The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent (>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days
- •Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
- •Male or female 18 - 65 years
- •Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination
- •Willing and able to provide written informed consent prior to participation in the clinical investigation
- •Willing and able to comply with all study related procedure
排除标准
- •Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test)
- •Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1)
- •Systemic steroid treatment less than 4 weeks before the inclusion in the study
- •Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
- •History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
- •Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
- •Current malignancy of any kind
- •Known allergy to polyvinylchloride or medicinal liquid paraffin
- •Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk
- •Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region
- •Previous treated with radiation on the face, head or neck regions
- •Female patients who are pregnant or nursing, or become pregnant at any time from first visit at ENT(Ear, Nose and Throat) - clinic until treatment day (second visit)
- •Female patients: unwilling to use adequate contraceptive between first and last visit
- •Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
结局指标
主要结局
Pain score on the Visual Analogue Scale
时间窗: Five seconds after placement of catheter in nasal cavity
To evaluate whether patient´s self-administration of catheter into nasal cavity is associated with a different degree of patient-reported pain on Visual Analogue Scales (VAS) compared to when administered by a health professional.
次要结局
- Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire(Baseline, day 14)
研究者
Finn Jorgensen
Finn Jorgensen, M.D., Ph.D.
Halmstad County Hospital
研究点 (1)
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