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

N/ACompletedNCT06992037

Aerin Medical1,110 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

1,110

Conditions

Nasal Airway Obstruction

Eligibility

Sex: ALLMin age: 22 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chicago Nasal & Sinus Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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