NCT02230423

Brief Summary

This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

April 28, 2014

Last Update Submit

October 11, 2018

Conditions

Empty Nose Syndrome

Keywords

Functional nasal surgeryEmpty Nose Syndrome (ENS)

Outcome Measures

Primary Outcomes (1)

  • Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression

    Up to 1 year post-surgery

Secondary Outcomes (1)

  • Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery

    Up to 1 year post-op

Study Arms (1)

Patients receiving nose surgery

EXPERIMENTAL

Patients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without "Empty Nose Syndrome".

Procedure: Nasal surgery

Interventions

Nasal surgeryPROCEDURE
Also known as: Septoplasty, Turbinoplasty, Removal of turbinates and septum parts
Patients receiving nose surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing a primary septoplasty and/or turbinoplasty
  • Patients suffering from empty nose syndrome after measurably successful nasal surgery
  • Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor patients)

You may not qualify if:

  • Patients with known neurologic disorders that could compromise perception threshold measurements
  • Patients with known allergies/intolerance to test agents that are used to measure perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)
  • Inability to judge or understand the testing or the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Nasal Surgical Procedures

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Michael Soyka, Dr.med.

    Zurich University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

September 3, 2014

Study Start

May 1, 2015

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)