- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02136043
Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure
May 25, 2015 updated by: Finn Jorgensen, Halmstad County Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Halmstad, Sweden
- Ear, Nose and Throat Dept, Halmstad County Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Insertion of catheter into nasal cavity carried out by patient.
Fixation of catheter during treatment with patient´s hand.
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|
Experimental: Group 2
Insertion of catheter into nasal cavity carried out by health professional.
Fixation of catheter during treatment with helmet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score on the Visual Analogue Scale
Time Frame: 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.
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Five seconds after placement of catheter in nasal cavity
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire
Time Frame: 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.
|
Baseline, day 14
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Nasal Inspiratory Flow (PNIF)
Time Frame: Baseline, day 14
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Finn Jorgensen, M.D., Ph.D., Halmstad County Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
May 5, 2014
First Submitted That Met QC Criteria
May 8, 2014
First Posted (Estimate)
May 12, 2014
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 25, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHC14.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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