An interventional study of Drug-induced Sleep Endoscopy findings (identified obstruction sites) in Obstructive Sleep Apnea of Child, sponsored by Regional Hospital West Jutland. Not yet recruiting at 1 site in Denmark. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Regional Hospital West Jutland · Not applicable, Interventional, and Diagnostic
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.
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.
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.
3.1 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.
4.1 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.
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
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.
This study's planned enrollment of 250 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Regional Hospital West Jutland is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
Also known as: Turbinoplasty, Nasal steroids
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
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
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
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
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
Plan to share: Undecided
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Regional Hospital West Jutland