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

NCT06992037 | Completed

• 1 other identifier: CTP2144
• Study Type: observational
• Target: 1,110
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nasal Airway Obstruction

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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

  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.

  Jan 2013- Dec 2025

• Epworth Sleepiness Scale (ESS)

  The ESS is a validated widely used self-administered screening questionnaire that evaluates excessive daytime sleepiness.

  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

  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

  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

  Jan 2013 - Dec 2025

Study Arms (4)

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

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (1)

Chicago Nasal & Sinus Center

Chicago, Illinois, 60602, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 28, 2025
• Study Start: March 14, 2025
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)