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

Not Applicable

Completed

• Conditions: Non-allergic Rhinitis.
• Interventions: Device: PBASE system 1.1 (active treatment)

• Registration Number: NCT02136043
• Lead Sponsor: Halmstad County Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	PBASE system 1.1 (active treatment)	Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet.
Group 1	PBASE system 1.1 (active treatment)	Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand.

Primary Outcome Measures

Name	Time	Method
Pain score on the Visual Analogue Scale	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ear, Nose and Throat Dept, Halmstad County Hospital; 🇸🇪 Halmstad, Sweden