Incompetence of Nasal Valve
Conditions
Brief summary
Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far, and would help the clinicians to advise the use of any of these dilators. From clinical experience, endonasal dilators are well supported and improve breathing better than the external dilators
Detailed description
Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far,
Interventions
DEVICENasal dilator Nasanita
Nasal Dilator
DEVICENasal dilator Nozovent
DEVICENasal dilator Breath Right
DEVICENasal dilator Airmax
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients with nasal obstruction due to external nasal valve problems and with positive Cottle sign. Age \> 18 and \< 60 years. Ability to give reliable information and written informed consent.
Exclusion criteria
Patients with nasal obstruction due to other endonasal anatomic deformities besides external nasal valve dysfunction. Patients with rhinosinusitis and/or nasal polyps evaluated by nasal endoscopy. Patients with chronic lower airway disease like severe asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis and/or other conditions that interfere with the generation of a reliable Peak Nasal Inspiratory Flow (PNIF) result.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Nasal Inflammatory Flow | 4 weeks | Change in Peak Nasal Inflammatory Flow between the 4 different dilators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| preference | 4 weeks | Patients' preference of 2 out of 4 dilators tested at baseline for a trial period of 4 week duration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| surgery | 4 weeks | Patients' preference to continue to use the preferred dilator after the 4 weeks' trial period or choice to undergo surgery after one month of usage of the preferred dilator. |
| reasons of choice | 4 weeks | Specific reasons for the choice of the two dilators at baseline (functional vs aesthetic) at baseline |
Countries
Belgium
Outcome results
None listed