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

Obstructive Sleep Apnea of Child Clinical Trial

— DISE  

Official title:

Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093802
• Other study ID #: MHildebrandt
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: July 1, 2029

Study information

• Verified date: October 2023
• Source: Regional Hospital West Jutland
• Contact: Mascha Hildebrandt, MD
• Phone: +4541289051
• Email: mascha.hilde[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: July 1, 2029
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Child
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Denmark	Regional Hospital Gødstrup	Herning	Region Of Central Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Regional Hospital West Jutland	University Hospital, Antwerp

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	one year post surgery
Secondary	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.	initial assessment and one year post surgery
Secondary	OSA (AHI)	Change in apnea-hypopnea index (AHI): Analyzing AHI and oxygen saturation differences between baseline and post-treatment in both groups.	initial assessment and one year post surgery
Secondary	Quality of Life (OSA-18)	Evaluation of symptom changes and quality of life using the OSA-18 questionnaire in both groups.	initial assessment and one year post surgery
Secondary	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.	initial assessment and one year post surgery