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

• Conditions: Nasal Airway Obstruction

• Registration Number: NCT06992037
• Lead Sponsor: Aerin Medical

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).

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 Timeline

• Study Start: 2025-03-14
• Study First Submitted: 2025-04-09
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Study Completion: 2025-05
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal Obstruction Symptom Scale (NOSE) Score	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)	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)	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)	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)	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)	Jan 2013 - Dec 2025	The ESS is a validated widely used self-administered screening questionnaire that evaluates excessive daytime sleepiness.
Change in Medication Dose	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	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	Jan 2013 - Dec 2025	Change in use of devices used for Nasal Airway Obstruction from prior to procedure to Post Procedure

Trial Locations

Locations (1)

Chicago Nasal & Sinus Center; 🇺🇸 Chicago, Illinois, United States