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Starting soon Not applicable

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

NCT06093802 · tracked via the Priya Life Science Denmark tracker
Sponsor
Regional Hospital West Jutland
Phase
Not applicable
Started
2025-01-01
Last updated
2023-10-23

Condition(s) studied

Obstructive Sleep Apnea of Child

Investigational drug(s) / intervention(s)

Drug-induced Sleep Endoscopy findings (identified obstruction sites)

Drug-induced Sleep Endoscopy findings (identified obstruction sites): As described above

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity * One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ) * Home Respiratory Polygraphy (HRP) and/or in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF Exclusion Criteria: * Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways * Neurological conditions affecting upper airway muscle tone * Lower airway disease (tracheomalacia, asthma) * Previous surgery of the nose/pharynx/larynx

Primary outcome measure(s)

  • Treatment Failure Rate — one year post surgery
    Proportion of patients, who exhibit persistent OSA post-surgery in the DISE-guided surgery group compared to the non-DISE-guided surgery group (controls).

Trial sites (1)

FacilityCityRegionStatus
Regional Hospital Gødstrup Herning Region of Central Jutland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06093802 on ClinicalTrials.gov ↗ ← All trials in Denmark