Clinical trial NCT06992037: An Ambispective Registry Study Comparing Clinical Outcomes of Surgical Interventions for the Treatment of Nasal Airway Obstruction.
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)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nasal Airway Obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nasal Obstruction Symptom Scale (NOSE) Score
timeFrame: Jan 2013 - Dec 2025
measure: 22-Item Sinonasal Nasal Outcome Test (SNOT-22)
timeFrame: Jan 2013 - Dec 2025
measure: Standard Cosmesis and Health Outcomes Survey (SCHNOS)
timeFrame: Jan 2013 - Dec 2025
measure: Short Form-12 (SF-12 version 1)
timeFrame: Jan 2013 - Dec 2025
measure: Mini-Rhinoconjunctivitis Quality of Life Score (Mini-RQLQ)
timeFrame: Jan 2013- Dec 2025
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Jan 2013 - Dec 2025
measure: Change in Medication Dose
timeFrame: Jan 2013 - Dec 2025
measure: Change in Medication Frequency
timeFrame: Jan 2013 - Dec 2025
measure: Change in use of Nasal Airway Obstruction Devices
timeFrame: Jan 2013 - Dec 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Nasal & Sinus Center
state: Illinois
Study officials:
References: