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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand. |
|
| Group 2 | Experimental | Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBASE system 1.1 (active treatment) | Device |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Nasal Inspiratory Flow (PNIF) | To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by PNIF is different between treatment groups. | Baseline, day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finn Jorgensen, M.D., Ph.D. | Halmstad County Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ear, Nose and Throat Dept, Halmstad County Hospital | Halmstad | Sweden |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |