NCT03331107

Brief Summary

Nasal obstruction is a very subjective sensation but it's also a frequent reason of consultation. Two specific questionnaire NOSE and RhinoQOL were validated; but rhinomanometry value is still a question to debate. As well as the difference between acoustic rhinometry and rhinomanometry. Usually nasal obstruction due to a septal deviation is treated by septoplasty. If the anatomic result can be proved true, the patient's felt would be unsuccessful. The aim of this study is to assess the impact of septoplasty on the nasal obstruction, objectively by rhinometry and subjectively by questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

October 24, 2017

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nose Obstruction symptom Evaluation

    scale about nose obstruction filled up by the patient

    3 months

  • nasal resistance to airflow

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient admitted for septoplasty in Institut Arthur Vernes

You may qualify if:

  • age \>18
  • with medical insurance
  • programmed for septoplasty
  • nasal obstruction with septal deviation
  • accept participation

You may not qualify if:

  • nasal sine polyposis
  • endonasal mass
  • chronic sinusite
  • previous nasal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 6, 2017

Study Start

December 5, 2016

Primary Completion

December 31, 2017

Study Completion

January 1, 2019

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations