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Clinical Trial Summary

The primary aim of the study is to create a model; in order to examine the effects of neural trauma in patients that are healthy individuals, induced by controlled nasal fractures during rhinoplasty, and the regeneration process in the weeks/months that follow. This study includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score, peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal provocation (response to capsaicin and cold dry air (CDA) exposure).


Clinical Trial Description

The investigators will set up a prospective mono-center study. The investigators will utilize objective and subjective parameters in order to assess trigeminal nerve function at the level of the nasal mucosa before and after septorhinoplasty (as a model of controlled nasal fractures). The subjective parameters involve a visual analogue scale (VAS) score for each individual nasal symptom (nasal obstruction, facial pain/pressure, headache, rhinorrhea, sneezing, pruritus, post nasal drip, and loss of smell). An objective assessment includes measurement of PNIF (Peak Nasal Inspiratory Flow), the presence of neuropeptides in nasal secretions, (by introducing merocels and removing them 5 minutes later), short cold dry air (CDA) provocation and capsaicin provocation with subsequent measurements of PNIF and VAS scores and neuropeptides. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT02733783
Study type Interventional
Source Katholieke Universiteit Leuven
Contact
Status Not yet recruiting
Phase N/A
Start date April 2016
Completion date December 2017