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

NCT06093802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea of Child

Interventions

DIAGNOSTIC_TEST

Drug-induced Sleep Endoscopy findings (identified obstruction sites)

As described above

Sponsors & Collaborators

  • University Hospital, Antwerp

    collaborator OTHER

  • Regional Hospital West Jutland

    lead OTHER

Principal Investigators

  • Therese E Ovesen, Prof. DMSc · Regional Hospital West Jutland

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2029-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093802 on ClinicalTrials.gov