Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-07 @ 2:13 PM
Study NCT ID:
NCT06093802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.
Sponsor:
Regional Hospital West Jutland
Organization:
Study Overview
Official Title:
Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISE
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: