NCT04017923

Brief Summary

Background: It is predicted that the nasal tip support will decrease with aging due to weakening of cartilage and connective tissues. However, there is no consensus on the age at which this change began. It is quite difficult to evaluate the nasal tip support, while the ideal nasal tip support pressure is also not known. The aim of this study is to determine the nasal tip support pressure alterations in various age groups, by measuring nasal tip support with a Newton meter, according to age and gender. Methods: This prospective clinical study was conducted between January 2019 and April 2019 at a tertiary health facility. Nasal tip resistances in 4 different age groups, as 20-29, 30-39, 40-64 and 65 years and older, were measured with a digital Newton meter. A total number of 159 patients with a minimum of 36 patients in each age group were included in the study. Nasal tip resistance measurements were compared among nasal tip displacement distances of 2mm, 3mm and 4mm, according to age groups and gender.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 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

March 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 7, 2019

Last Update Submit

July 12, 2019

Conditions

Keywords

Nasal tipTip supportRhinoplastyNasal cartilageAge

Outcome Measures

Primary Outcomes (1)

  • Measurement of nasal tip resistance

    A digital newton meter was used to measure the nasal tip resistance

    All measurements were obtained within 2 months. (march 01-May 01)

Study Arms (4)

20-29 age group

Diagnostic Test: measurement of nasal tip support in different age groups.

30-39 age group

Diagnostic Test: measurement of nasal tip support in different age groups.

40-64 age group

Diagnostic Test: measurement of nasal tip support in different age groups.

65 and older age group

Diagnostic Test: measurement of nasal tip support in different age groups.

Interventions

Nasal tip resistances , were measured in all age groups with a digital Newton meter.

20-29 age group30-39 age group40-64 age group65 and older age group

Eligibility Criteria

Age20 Years - 84 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older

You may qualify if:

  • Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older. A total of 159 patients with a minimum of 36 patients in each group were included in the study.

You may not qualify if:

  • Patients with a history of nasal trauma, previous nasal surgery (septoplasty, rhinoplasty, tumor surgery), severe deviation of the caudal septum, visible external nasal deviation, and systemic disease affecting the connective tissue were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alper Koycu

Ankara, Cankaya, 06810, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D.

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 12, 2019

Study Start

March 1, 2019

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations