Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-allergic Rhinitis.

Intervention / Treatment
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* Device: PBASE system 1.1 (active treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand. | Device: PBASE system 1.1 (active treatment)<br> <br> |
| Experimental: Group 2<br>Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet. | Device: PBASE system 1.1 (active treatment)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on the Visual Analogue Scale | 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. | Five seconds after placement of catheter in nasal cavity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire | To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by SNOT-22 is different between treatment groups. | Baseline, day 14 |