Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02733783
Status:
UNKNOWN
Last Update Posted:
2016-04-12
First Post:
2016-03-17
Brief Title:
Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 weeksmonths 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
Detailed 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 painpressure 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None