Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061257) titled 'Impact of Septorhinoplasty on Obstructive Sleep Apnea and Nasal Symptoms: A Prospective Observational Study' on April 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - The Jikei University

Condition: Condition - Nasal obstruction; Obstructive sleep apnea; Deviated nasal septum Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate, from both subjective and objective perspectives, the extent to which improvement in nasal airflow following OSRP contributes to changes in the severity of OSA and patient-reported nocturnal nasal obstruction symptoms. In addition, this study will exploratorily assess the potential for resumption of treatment in patients in whom nasal obstruction had interfered with the initiation or continuation of continuous positive airway pressure (CPAP) therapy. Furthermore, it aims to investigate the prevalence of undiagnosed OSA among patients undergoing OSRP primarily for nasal obstruction. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Open septorhinoplasty will be performed, and daytime sleepiness questionnaires and portable sleep apnea monitor assessments will be conducted before and after surgery.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients undergoing open septorhinoplasty (OSRP) at the Department of Plastic and Reconstructive Surgery, The Jikei University Hospital; age over 18 years; patients able to undergo both preoperative and postoperative assessments, including the Japanese version of the Standardized Cosmesis and Health Nasal Outcomes Survey (J-SCHNOS), the Japanese version of the Epworth Sleepiness Scale (JESS), and portable sleep apnea testing; patients who provide written informed consent to participate in this study Key exclusion criteria - Patients deemed unlikely to complete follow-up through 12 months postoperatively; patients for whom study assessments are considered inappropriate due to severe comorbidities or acute illnesses; pregnant patients or those who may be pregnant; patients who are not native Japanese speakers; patients with a history of craniofacial trauma within the past 3 months Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Date of IRB - 2026 Year 04 Month 13 Day Anticipated trial start date - 2026 Year 04 Month 20 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069331

Disclaimer: Curated by HT Syndication.