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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Drug-induced Sleep Endoscopy findings (identified obstruction sites)
Diagnostic testAs described above
Treatment groups
Trial outcomes
Primary outcomes
Treatment Failure Rate
Proportion of patients, who exhibit persistent OSA post-surgery in the DISE-guided surgery group compared to the non-DISE-guided surgery group (controls).
Secondary outcomes
DISE findings
Evaluation of DISE findings and pediatric VOTE: Assessing obstruction degree and sites in both groups. Quality of Life Improvement: DISE-score and Airway Obstruction Pattern: Identifying and comparing anatomical obstruction sites and severity during DISE in both groups.
OSA (AHI)
Change in apnea-hypopnea index (AHI): Analyzing AHI and oxygen saturation differences between baseline and post-treatment in both groups.
Quality of Life (OSA-18)
Evaluation of symptom changes and quality of life using the OSA-18 questionnaire in both groups.
Sedation-related and surgical complications
Adverse Events and Complications: Investigation of the incidence and severity of sedation-related events and surgical complications in both groups, including postoperative hemorrhage, infection, recurrent symptoms post-tonsillotomy, and symptom improvement without treatment.
Sponsors and contacts
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Regional Hospital West Jutland
Lead sponsor
University Hospital, Antwerp
Collaborator
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