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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea of Child
• Intervention / Treatment: Diagnostic test: Drug-induced Sleep Endoscopy findings (identified obstruction sites)

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

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mascha Hildebrandt, MD; Phone Number: +4541289051; Email: mascha.hilde@gmail.com
• Study Contact Backup: Name: Jannik Bertelsen, MD PhD; Email: jannik.bertelsen@auh.rm.dk

Study Locations

• Denmark
  • Region Of Central Jutland
    • Herning, Region Of Central Jutland, Denmark, 7400
      • Regional hospital Gødstrup
      • Contact: Therese E Ovesen, Prof. DMSc; Email: theroves@rm.dk
      • Contact: Anne Louise Bach Christensen, MD; Email: anebch@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DISE-guided treatment group; DISE findings will be documented and obstruction scored per pediatric DISE criteria. Clinically relevant obstruction is defined as >50% at minimum one site. (Adeno-)tonsillotomy will be performed if corroborative DISE suggests tonsil/adenoid obstruction; if not, no surgery will be performed. This approach is maintained despite other identified obstruction sites, which will be assessed at a later stage.	Diagnostic test: Drug-induced Sleep Endoscopy findings (identified obstruction sites); As described above; Other Names: Turbinoplasty; Nasal steroids
Active Comparator: Non-DISE-guided treatment group; DISE findings will be documented, and video material will be saved for later assessment. Patients will be operated according to current guidelines (s.o.), regardless of perioperative DISE findings, i.e. tonsillotomy +/- adenoidectomy.	Diagnostic test: Drug-induced Sleep Endoscopy findings (identified obstruction sites); As described above; Other Names: Turbinoplasty; Nasal steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Regional Hospital West Jutland
• Collaborators: University Hospital, Antwerp
• Investigators: Study Director: Therese E Ovesen, Prof. DMSc, Regional Hospital West Jutland

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Drug-induced Sleep Endoscopy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MHildebrandt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No