Clinical trial NCT06093802: Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.
Official title: Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Child
Keywords: Drug-induced Sleep Endoscopy
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2023-10-23
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Background

1.1 Pediatric Obstructive Sleep Apnea

Pediatric OSA ranges from simple snoring to severe upper airway obstruction during sleep. Left untreated, it can lead to significant health issues, especially in children, impacting their cognitive development, learning, and social interactions.

1.2 Diagnostics and Surgical Strategies

Polysomnography (PSG) is the gold standard for diagnosing OSA. In Denmark, PSG isn't widely used due to equipment and setup constraints.

Surgical treatment for pediatric OSA in Denmark relies primarily on clinical examination of the tonsils and parental reports of symptoms.

1.3 Drug-Induced Sleep Endoscopy (DISE)

DISE is a method for visualizing upper airway collapse during sleep using a flexible endoscope. It is increasingly used to guide surgical decisions for pediatric OSA in various countries, though its clinical impact remains uncertain.

2. Aims

This research project aims to evaluate the impact of DISE-guided surgical interventions on pediatric OSA outcomes and compare the effectiveness of a DISE-inclusive diagnostic approach with the traditional pediatric OSA workup. The specific objectives are:

Evaluate treatment outcomes, including the reduction in persistent OSA post-surgery.

Classify and compare patterns of airway obstruction observed during DISE in surgically naive children.

Compare diagnostic approaches in terms of cost, time, and benefits. Identify adverse events and complications related to sedation and surgery. Assess the feasibility of DISE in Danish patients through a pilot study.

3. Methods

3.1 Randomized Controlled Trial (RCT)

Patients undergo initial clinical examination and home respiratory polygraphy (HRP). Based on AAO-HNSF criteria, patients with OSA will undergo DISE. The sample size for the RCT is 250 patients, with 125 in each group.

3.2 Statistics

Statistical analysis will involve Chi-square tests, logistic regression, and T-tests for comparisons between groups.

3.3 Sedation Protocol

Sedation will use propofol to induce a state similar to natural sleep, guided by preoperative polysomnography.

3.4 Assessment of Obstruction

Obstruction characteristics will be documented using the International Pediatric Sleep Endoscopy Scale (IPSES).

3.5 Follow-up

Patients will have two follow-up appointments at three and 12 months postoperatively, including clinical examination, HRP, and re-DISE at three months for both groups.

4. Outcomes

4.1 Primary Outcome

The primary outcome is the treatment failure rate, comparing the proportion of patients with persistent OSA post-surgery in the DISE-guided surgery group to the non-DISE-guided surgery group.

4.2 Secondary Outcomes

Secondary outcomes include evaluation of DISE findings, changes in apnea-hypopnea index (AHI), quality of life improvement, DISE-score/airway obstruction pattern, and identification of adverse events and complications.

4.3 Confounding Factors

Population characteristics, such as age, obesity (BMI), and gender, will be considered.

5. Ethical Considerations

In cases where no obstruction is identified related to tonsils or adenoids, alternative treatment options will be discussed with parents. Privacy and informed consent are required. The study will follow ethical and data protection regulations

Eligibility criteria: 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 outcomes:
measure: Treatment Failure Rate
timeFrame: one year post surgery
Secondary outcomes:
measure: DISE findings
timeFrame: initial assessment and one year post surgery
measure: OSA (AHI)
timeFrame: initial assessment and one year post surgery
measure: Quality of Life (OSA-18)
timeFrame: initial assessment and one year post surgery
measure: Sedation-related and surgical complications
timeFrame: initial assessment and one year post surgery
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regional Hospital Gødstrup
state: Region Of Central Jutland
Study officials:
affiliation: Regional Hospital West Jutland
name: Therese E Ovesen, Prof. DMSc
role: STUDY_DIRECTOR
References: