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

Primary Purpose

Non-allergic Rhinitis.

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PBASE system 1.1 (active treatment)
Sponsored by
Halmstad County Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-allergic Rhinitis.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ear, Nose and Throat Dept, Halmstad County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand.

Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 5, 2014
Last Updated
May 25, 2015
Sponsor
Halmstad County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02136043
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Halmstad County Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-allergic Rhinitis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet.
Intervention Type
Device
Intervention Name(s)
PBASE system 1.1 (active treatment)
Primary Outcome Measure Information:
Title
Pain score on the Visual Analogue Scale
Description
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.
Time Frame
Five seconds after placement of catheter in nasal cavity
Secondary Outcome Measure Information:
Title
Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire
Description
To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by SNOT-22 is different between treatment groups.
Time Frame
Baseline, day 14
Other Pre-specified Outcome Measures:
Title
Peak Nasal Inspiratory Flow (PNIF)
Description
To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by PNIF is different between treatment groups.
Time Frame
Baseline, day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn Jorgensen, M.D., Ph.D.
Organizational Affiliation
Halmstad County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ear, Nose and Throat Dept, Halmstad County Hospital
City
Halmstad
Country
Sweden

12. IPD Sharing Statement

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

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