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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorRegional Hospital West Jutland

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Drug-induced Sleep Endoscopy findings (identified obstruction sites)

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Regional Hospital West Jutland

Lead sponsor

University Hospital, Antwerp

Collaborator