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NOT YET RECRUITING
NCT06093802
NA

Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.

Sponsor: Regional Hospital West Jutland

View on ClinicalTrials.gov

Summary

Pediatric obstructive sleep apnea (OSA) can lead to severe health issues if untreated. While polysomnography is the gold standard for diagnosis, current surgical treatment in Denmark relies on caregiver reports and clinical exams. Approximately 25% of patients have persistent symptoms post-surgery, indicating the need for better diagnostic and treatment options. Drug-Induced Sleep Endoscopy (DISE) allows dynamic upper airway visualization during mild sedation, aiding in treatment decisions. This research project aims to evaluate the impact of DISE-guided interventions on pediatric OSA outcomes and compare its effectiveness and cost/benefit with traditional diagnostic approaches.

Official title: Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.

Key Details

Gender

All

Age Range

2 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-01-01

Completion Date

2029-07-01

Last Updated

2023-10-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Drug-induced Sleep Endoscopy findings (identified obstruction sites)

As described above

Locations (1)

Regional Hospital Gødstrup

Herning, Region of Central Jutland, Denmark