asal airway obstruction study - NAIROS

Not Applicable

Completed

• Conditions: Deviated septum; Ear, Nose and Throat

• Registration Number: ISRCTN16168569
• Lead Sponsor: ewcastle Upon Tyne NHS Foundation Trust

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32054508 protocol (added 17/02/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37852641/ (added 19/10/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38477237/ (added 13/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-24
• Study Completion: 2021-03-04
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

1. Adults aged =18 years with a baseline NOSE score =30
2. Septal Deflection visible at naseondoscopy
3. Capacity to provide informed written consent and complete the study questionnaires.

Exclusion Criteria

1. Patients <18 years
2. Patients with a baseline NOSE score <30
3. Any prior septal surgery
4. Systemic inflammatory disease
5. Granulomatosis with poly angiitis
6. Naseondoscopic evidence of unrelated associated pathology eg. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the prescence of polyposis or pus
7. Intranasal recreational drug use
8. Breastfeeding, pregnancy or intended pregnancy
9. Bleeding diathesis
10. Therapeutic anticoagulation
11. Known adverse reactions to general anaesthesia
12. Immunocompromised patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported assessment of nasal and general symptoms is assessed using the SNOT 22 questionnaire (Sinonasal Outcome Test) at baseline, 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
1. Objective assessment nasal airflow is measured using rhinospirometry (nasal partitioning ratio and peak nasal airflow measurements) at baseline, 6 and 12 months<br>2. Quality of life is measured using the Short Form 36 Quality of Life Questionnaire at baseline, 6 and 12 months<br>3. Health utilisation is measured using a health utilisation questionnaire at baseline, 6 and 12 months