Nasal Airway ObstructionDUONCT06992037
An Ambispective Registry Study Comparing Clinical Outcomes of Surgical Interventions for the Treatment of Nasal Airway Obstruction.
An observational study of Nasal Airway Obstruction, run by Aerin Medical at 1 site in United States.
Trial summary
The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO). Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Nasal Airway Obstruction
- How many people
- 1,110 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 21 Jul 2025
- How long will I take part?
- 1 Day
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with nasal airway obstruction that had either a functional rhinoplasty or septoturbinoplasty within the time frame of January 01, 2013 to December 31, 2023 or a TCRF procedure between the dates of November 19, 2015 to December 31, 2023.
Who may be able to join
- Age 22 to 85 years old (inclusively).
- Sought treatment at the clinic for nasal airway obstruction.
- Had either a functional rhinoplasty or septoturbinoplasty within the time frame of January 01, 2013 to December 31, 2023 or a Temperature-Controlled Radiofrequency (TCRF) procedure between the dates of November 19, 2015 to December 31, 2023.
- Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
- Willing and able to provide consent.
- Willing and able to complete the survey, including patient-reported outcome measures.
- Willing and able to comply with the patient-specific requirements outlined in the study protocol.
Who cannot join
- Had extreme nasal pathology or a history of extreme nasal injuries.
- Had cosmetic rhinoplasty with no functional component.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Nasal & Sinus Center
Chicago, Illinois, 60602
About this study
Official title: An Ambispective, Multicenter, Registry Study Comparing Clinical Outcomes of Participants Receiving Surgical Interventions for the Treatment of Nasal Airway Obstruction (The DUO Study)
The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO).
Read the detailed description
This is a multicenter, ambispective registry study. The study will include assessment of prospective, long term outcomes by remote administration of patient reported outcome questionnaires. Participants identified in Part 1 of the study with outcomes available for at least 12 months following their surgical procedure for nasal airway obstruction will be identified by the treating physician and invited to participate in the long-term follow-up study. Participants agreeing to participate will be asked to complete a series of questions about their health experience following their surgery and will be asked to complete select health outcome questionnaires using a secure electronic survey platform.
- Conditions
- Nasal Airway Obstruction
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functional Rhinoplasty | Patients received a non-study/Standard of Care Functional Rhinoplasty within the past 5 years | |
| Septoplasty | Patients received a non-study/Standard of Care Septoplasty within the past 5 years | |
| Vivaer | Patients received a Vivaer procedure (radiofrequency) within the past 5 years | |
| Rhinaer | Patients received a Rhinaer procedure (radiofrequency) within the past 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction Symptom Scale (NOSE) Score
The NOSE survey is a disease-specific questionnaire designed to measure nasal obstruction. It is commonly used in otolaryngology practice to provide an objective measure of nasal obstruction. Patients rate on a 0-4 scale questions regarding congestion, ability to get air in nose during exercise, and others. Scores result in symptom severity classes of mild, moderate, severe or extreme NAO.
Measured: Jan 2013 - Dec 2025
22-Item Sinonasal Nasal Outcome Test (SNOT-22)
The The Sino-Nasal Outcome Test (SNOT-22) Questionnaire is a validated patient-reported outcome measure established to delineate the presence and severity of sinonasal disorders. It is a widely used questionnaire for assessing the impact of chronic rhinosinusitis on a patient's quality of life.
Minimum possible score: 0; Maximum possible score: 110. Higher scores indicate: A worse outcome, meaning more severe symptoms and a greater negative impact on quality of life.
Measured: Jan 2013 - Dec 2025
Standard Cosmesis and Health Outcomes Survey (SCHNOS)
The SCHNOS survey is a validated 10-item survey with two-domains (nasal obstruction and nasal cosmesis) patient-reported outcomes survey designed to evaluate both functional and cosmetic components of rhinoplasty. Minimum possible score: 0, Maximum possible score: 40. Higher scores indicate: A better outcome, meaning improved nasal function and cosmesis.
Measured: Jan 2013 - Dec 2025
Short Form-12 (SF-12 version 1)
SF-12 is a 12 question self-reported outcome measure assessing the impact of health on an individual's everyday life. It includes questions in 8 domains: limitations in physical activities due to health problems, limitations in social activities because of physical or emotional problems, limitations on usual role activities because of physical or emotional health problems, bodily pain, general mental health, vitality, and general health perceptions. A score above 50 indicates better than average health-related quality of life and scores less than 50 suggest below-average health. Minimum possible score: 0, Maximum possible score: 100. Higher scores indicate: A better outcome, meaning improved health-related quality of life
Measured: Jan 2013 - Dec 2025
Mini-Rhinoconjunctivitis Quality of Life Score (Mini-RQLQ)
The mini-RQLQ is a self-administered questionnaire that measures functional impairments that are most troublesome to adult patients because of their rhinoconjunctivitis. This instrument has 14 questions in 5 domains: activity limitation, practical problems, nose symptoms, eye symptoms and non-nose/eye symptoms). Minimum possible score: 0, Maximum possible score: 42. Higher scores indicate: A worse outcome, meaning more severe symptoms and a greater negative impact on quality of life.
Measured: Jan 2013- Dec 2025
Epworth Sleepiness Scale (ESS)
The ESS is a validated widely used self-administered screening questionnaire that evaluates excessive daytime sleepiness.
Measured: Jan 2013 - Dec 2025
Change in Medication Dose
Change in the dose from prior to procedure to post procedure of medication used for treating Nasal Airway Obstruction Symptoms
Measured: Jan 2013 - Dec 2025
Change in Medication Frequency
Change in the frequency of use (prior to procedure to post procedure) of medication used for treating Nasal Airway Obstruction Symptoms
Measured: Jan 2013 - Dec 2025
Change in use of Nasal Airway Obstruction Devices
Change in use of devices used for Nasal Airway Obstruction from prior to procedure to Post Procedure
Measured: Jan 2013 - Dec 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start14 Mar 2025
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Airway ObstructionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,110 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aerin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992037
- Sponsor's protocol ID
- CTP2144
- Acronym
- DUO
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ambispective, Multicenter, Registry Study Comparing Clinical Outcomes of Participants Receiving Surgical Interventions for the Treatment of Nasal Airway Obstruction (The DUO Study)
- ClinicalTrials.gov ID
- NCT06992037
- Acronym / sponsor ID
- DUO / CTP2144
- Conditions
- Nasal Airway Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- Aerin MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 28 May 2025 (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.
The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO).
Detailed description
This is a multicenter, ambispective registry study. The study will include assessment of prospective, long term outcomes by remote administration of patient reported outcome questionnaires. Participants identified in Part 1 of the study with outcomes available for at least 12 months following their surgical procedure for nasal airway obstruction will be identified by the treating physician and invited to participate in the long-term follow-up study. Participants agreeing to participate will be asked to complete a series of questions about their health experience following their surgery and will be asked to complete select health outcome questionnaires using a secure electronic survey platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Functional Rhinoplasty | – | –Patients received a non-study/Standard of Care Functional Rhinoplasty within the past 5 years |
| Septoplasty | – | –Patients received a non-study/Standard of Care Septoplasty within the past 5 years |
| Vivaer | – | –Patients received a Vivaer procedure (radiofrequency) within the past 5 years |
| Rhinaer | – | –Patients received a Rhinaer procedure (radiofrequency) within the past 5 years |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nasal airway obstruction that had either a functional rhinoplasty or septoturbinoplasty within the time frame of January 01, 2013 to December 31, 2023 or a TCRF procedure between the dates of November 19, 2015 to December 31, 2023.
Key inclusion criteria (7 listed)
- Age 22 to 85 years old (inclusively).
- Sought treatment at the clinic for nasal airway obstruction.
- Had either a functional rhinoplasty or septoturbinoplasty within the time frame of January 01, 2013 to December 31, 2023 or a Temperature-Controlled Radiofrequency (TCRF) procedure between the dates of November 19, 2015 to December 31, 2023.
- Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
- Willing and able to provide consent.
Key exclusion criteria (2 listed)
- Had extreme nasal pathology or a history of extreme nasal injuries.
- Had cosmetic rhinoplasty with no functional component.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasal Obstruction Symptom Scale (NOSE) Score
Time frame: Jan 2013 - Dec 2025
The NOSE survey is a disease-specific questionnaire designed to measure nasal obstruction. It is commonly used in otolaryngology practice to provide an objective measure of nasal obstruction. Patients rate on a 0-4 scale questions regarding congestion, ability to get air in nose during exercise, and others. Scores result in symptom severity classes of mild, moderate, severe or extreme NAO.
22-Item Sinonasal Nasal Outcome Test (SNOT-22)
Time frame: Jan 2013 - Dec 2025
The The Sino-Nasal Outcome Test (SNOT-22) Questionnaire is a validated patient-reported outcome measure established to delineate the presence and severity of sinonasal disorders. It is a widely used questionnaire for assessing the impact of chronic rhinosinusitis on a patient's quality of life. Minimum possible score: 0; Maximum possible score: 110. Higher scores indicate: A worse outcome, meaning more severe symptoms and a greater negative impact on quality of life.
Standard Cosmesis and Health Outcomes Survey (SCHNOS)
Time frame: Jan 2013 - Dec 2025
The SCHNOS survey is a validated 10-item survey with two-domains (nasal obstruction and nasal cosmesis) patient-reported outcomes survey designed to evaluate both functional and cosmetic components of rhinoplasty. Minimum possible score: 0, Maximum possible score: 40. Higher scores indicate: A better outcome, meaning improved nasal function and cosmesis.
Short Form-12 (SF-12 version 1)
Time frame: Jan 2013 - Dec 2025
SF-12 is a 12 question self-reported outcome measure assessing the impact of health on an individual's everyday life. It includes questions in 8 domains: limitations in physical activities due to health problems, limitations in social activities because of physical or emotional problems, limitations on usual role activities because of physical or emotional health problems, bodily pain, general mental health, vitality, and general health perceptions. A score above 50 indicates better than average health-related quality of life and scores less than 50 suggest below-average health. Minimum possible score: 0, Maximum possible score: 100. Higher scores indicate: A better outcome, meaning improved health-related quality of life
Mini-Rhinoconjunctivitis Quality of Life Score (Mini-RQLQ)
Time frame: Jan 2013- Dec 2025
The mini-RQLQ is a self-administered questionnaire that measures functional impairments that are most troublesome to adult patients because of their rhinoconjunctivitis. This instrument has 14 questions in 5 domains: activity limitation, practical problems, nose symptoms, eye symptoms and non-nose/eye symptoms). Minimum possible score: 0, Maximum possible score: 42. Higher scores indicate: A worse outcome, meaning more severe symptoms and a greater negative impact on quality of life.
Epworth Sleepiness Scale (ESS)
Time frame: Jan 2013 - Dec 2025
The ESS is a validated widely used self-administered screening questionnaire that evaluates excessive daytime sleepiness.
Change in Medication Dose
Time frame: Jan 2013 - Dec 2025
Change in the dose from prior to procedure to post procedure of medication used for treating Nasal Airway Obstruction Symptoms
Change in Medication Frequency
Time frame: Jan 2013 - Dec 2025
Change in the frequency of use (prior to procedure to post procedure) of medication used for treating Nasal Airway Obstruction Symptoms
Change in use of Nasal Airway Obstruction Devices
Time frame: Jan 2013 - Dec 2025
Change in use of devices used for Nasal Airway Obstruction from prior to procedure to Post Procedure
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 Airway Obstruction, run by Aerin Medical at 1 site in United States.
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 7 inclusion and 2 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 2 Nov 2026. 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 United States. 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?
Nasal Obstruction Symptom Scale (NOSE) Score (time frame: Jan 2013 - Dec 2025). The study lists 9 primary outcomes in all. 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 2 Nov 2026.