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Completed

NCT Number: NCT06992037

An Ambispective Registry Study Comparing Clinical Outcomes of Surgical Interventions for the Treatment of Nasal Airway Obstruction.

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).

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Key information

Conditions

Nasal Airway Obstruction Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chicago Nasal & Sinus Center

Chicago, Illinois, 60602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Had extreme nasal pathology or a history of extreme nasal injuries.
  • Had cosmetic rhinoplasty with no functional component.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

An Ambispective, Multicenter, Registry Study Comparing Clinical Outcomes of Participants Receiving Surgical Interventions for the Treatment of Nasal Airway Obstruction (The DUO Study)

Acronym: DUO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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