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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Failure Rate', 'timeFrame': 'one year post surgery', 'description': 'Proportion of patients, who exhibit persistent OSA post-surgery in the DISE-guided surgery group compared to the non-DISE-guided surgery group (controls).'}], 'secondaryOutcomes': [{'measure': 'DISE findings', 'timeFrame': 'initial assessment and one year post surgery', 'description': 'Evaluation of DISE findings and pediatric VOTE:\n\nAssessing obstruction degree and sites in both groups.\n\nQuality of Life Improvement:\n\nDISE-score and Airway Obstruction Pattern:\n\nIdentifying and comparing anatomical obstruction sites and severity during DISE in both groups.'}, {'measure': 'OSA (AHI)', 'timeFrame': 'initial assessment and one year post surgery', 'description': 'Change in apnea-hypopnea index (AHI):\n\nAnalyzing AHI and oxygen saturation differences between baseline and post-treatment in both groups.'}, {'measure': 'Quality of Life (OSA-18)', 'timeFrame': 'initial assessment and one year post surgery', 'description': 'Evaluation of symptom changes and quality of life using the OSA-18 questionnaire in both groups.'}, {'measure': 'Sedation-related and surgical complications', 'timeFrame': 'initial assessment and one year post surgery', 'description': 'Adverse Events and Complications:\n\nInvestigation 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-induced Sleep Endoscopy'], 'conditions': ['Obstructive Sleep Apnea of Child']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Background\n\n1.1 Pediatric Obstructive Sleep Apnea\n\nPediatric 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.\n\n1.2 Diagnostics and Surgical Strategies\n\nPolysomnography (PSG) is the gold standard for diagnosing OSA. In Denmark, PSG isn't widely used due to equipment and setup constraints.\n\nSurgical treatment for pediatric OSA in Denmark relies primarily on clinical examination of the tonsils and parental reports of symptoms.\n\n1.3 Drug-Induced Sleep Endoscopy (DISE)\n\nDISE 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.\n\n2\\. Aims\n\nThis 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:\n\nEvaluate treatment outcomes, including the reduction in persistent OSA post-surgery.\n\nClassify and compare patterns of airway obstruction observed during DISE in surgically naive children.\n\nCompare 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.\n\n3\\. Methods\n\n3.1 Randomized Controlled Trial (RCT)\n\nPatients 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.\n\n3.2 Statistics\n\nStatistical analysis will involve Chi-square tests, logistic regression, and T-tests for comparisons between groups.\n\n3.3 Sedation Protocol\n\nSedation will use propofol to induce a state similar to natural sleep, guided by preoperative polysomnography.\n\n3.4 Assessment of Obstruction\n\nObstruction characteristics will be documented using the International Pediatric Sleep Endoscopy Scale (IPSES).\n\n3.5 Follow-up\n\nPatients 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.\n\n4\\. Outcomes\n\n4.1 Primary Outcome\n\nThe 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.\n\n4.2 Secondary Outcomes\n\nSecondary 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.\n\n4.3 Confounding Factors\n\nPopulation characteristics, such as age, obesity (BMI), and gender, will be considered.\n\n5\\. Ethical Considerations\n\nIn 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity\n* One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ)\n* Home Respiratory Polygraphy (HRP) and/or in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF\n\nExclusion Criteria:\n\n* Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways\n* Neurological conditions affecting upper airway muscle tone\n* Lower airway disease (tracheomalacia, asthma)\n* Previous surgery of the nose/pharynx/larynx'}, 'identificationModule': {'nctId': 'NCT06093802', 'acronym': 'DISE', 'briefTitle': 'Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital West Jutland'}, 'officialTitle': 'Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.', 'orgStudyIdInfo': {'id': 'MHildebrandt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DISE-guided treatment group', 'description': '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.\n\nThis approach is maintained despite other identified obstruction sites, which will be assessed at a later stage.', 'interventionNames': ['Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-DISE-guided treatment group', 'description': 'DISE findings will be documented, and video material will be saved for later assessment.\n\nPatients will be operated according to current guidelines (s.o.), regardless of perioperative DISE findings, i.e. tonsillotomy +/- adenoidectomy.', 'interventionNames': ['Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites)']}], 'interventions': [{'name': 'Drug-induced Sleep Endoscopy findings (identified obstruction sites)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Turbinoplasty', 'Nasal steroids'], 'description': 'As described above', 'armGroupLabels': ['DISE-guided treatment group', 'Non-DISE-guided treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'state': 'Region of Central Jutland', 'country': 'Denmark', 'contacts': [{'name': 'Therese E Ovesen, Prof. DMSc', 'role': 'CONTACT', 'email': 'theroves@rm.dk'}, {'name': 'Anne Louise Bach Christensen, MD', 'role': 'CONTACT', 'email': 'anebch@rm.dk'}], 'facility': 'Regional Hospital Gødstrup', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'centralContacts': [{'name': 'Mascha Hildebrandt, MD', 'role': 'CONTACT', 'email': 'mascha.hilde@gmail.com', 'phone': '+4541289051'}, {'name': 'Jannik Bertelsen, MD PhD', 'role': 'CONTACT', 'email': 'jannik.bertelsen@auh.rm.dk'}], 'overallOfficials': [{'name': 'Therese E Ovesen, Prof. DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regional Hospital West Jutland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital West Jutland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mascha Eva Hildebrandt', 'investigatorAffiliation': 'Regional Hospital West Jutland'}}}}