Clinical trial NCT02136043: Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-allergic Rhinitis.
Lead sponsor: Halmstad County Hospital
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain score on the Visual Analogue Scale
timeFrame: Five seconds after placement of catheter in nasal cavity
Secondary outcomes:
measure: Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire
timeFrame: Baseline, day 14
Other outcomes:
measure: Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Baseline, day 14
Locations:
city: Halmstad
country: Sweden
facility: Ear, Nose and Throat Dept, Halmstad County Hospital
Study officials:
affiliation: Halmstad County Hospital
name: Finn Jorgensen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: