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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Diagnostic test

    As described above

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: DISE-guided treatment groupExperimental treatment 1 intervention
Group B: Non-DISE-guided treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
one year post surgery

Secondary outcomes

1

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.

Time frame
initial assessment and one year post surgery
2

OSA (AHI)

Change in apnea-hypopnea index (AHI): Analyzing AHI and oxygen saturation differences between baseline and post-treatment in both groups.

Time frame
initial assessment and one year post surgery
3

Quality of Life (OSA-18)

Evaluation of symptom changes and quality of life using the OSA-18 questionnaire in both groups.

Time frame
initial assessment and one year post surgery
4

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.

Time frame
initial assessment and one year post surgery

Other outcomes

Sponsors and contacts

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Regional Hospital West Jutland

Lead sponsor

University Hospital, Antwerp

Collaborator

This trial is not recruiting at the moment. You can still explore other options: