Nasal Valve IncompetenceNCT04017923
Measurement of Age and Sex Related Changes in Nasal Tip Support Using Digital Newton Meter
An observational study of Nasal Valve Incompetence and Alar Collapse, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Valve Incompetence, Alar Collapse
- What is being tested?
- measurement of nasal tip support in different age groups.
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age and Sex Related Changes in Nasal Tip Support
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.
Read more
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.
- Conditions
- Nasal Valve Incompetence, Alar Collapse
- Being tested
- measurement of nasal tip support in different age groups.
- Keywords
- Nasal tip, Tip support, Rhinoplasty, Nasal cartilage, Age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of nasal tip support in different age groups.Diagnostic test
Nasal tip resistances , were measured in all age groups with a digital Newton meter.
| Study group | Role | What they receive |
|---|---|---|
| 20-29 age group | Not described Receives: Diagnostic Test: measurement of nasal tip support in different age groups. | |
| 30-39 age group | Not described Receives: Diagnostic Test: measurement of nasal tip support in different age groups. | |
| 40-64 age group | Not described Receives: Diagnostic Test: measurement of nasal tip support in different age groups. | |
| 65 and older age group | Not described Receives: Diagnostic Test: measurement of nasal tip support in different age groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of nasal tip resistance
A digital newton meter was used to measure the nasal tip resistance
Measured: All measurements were obtained within 2 months. (march 01-May 01)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Mar 2019
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Valve IncompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Koycu, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017923
- Sponsor's protocol ID
- KA18/431
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Sex Related Changes in Nasal Tip Support
- ClinicalTrials.gov ID
- NCT04017923
- Acronym / sponsor ID
- KA18/431
- Conditions
- Nasal Valve Incompetence, Alar Collapse
- Keywords
- Nasal tip, Tip support, Rhinoplasty, Nasal cartilage, Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of nasal tip support in different age groups.Nasal tip resistances , were measured in all age groups with a digital Newton meter. | Diagnostic test | 20-29 age group, 30-39 age group, 40-64 age group, 65 and older age group |
Primary outcome
Measurement of nasal tip resistance
Time frame: All measurements were obtained within 2 months. (march 01-May 01)
A digital newton meter was used to measure the nasal tip resistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Valve Incompetence and Alar Collapse, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of nasal tip resistance (time frame: All measurements were obtained within 2 months. (march 01-May 01)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.