Status:
NOT_YET_RECRUITING
Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.
Lead Sponsor:
Regional Hospital West Jutland
Collaborating Sponsors:
University Hospital, Antwerp
Conditions:
Obstructive Sleep Apnea of Child
Eligibility:
All Genders
2-12 years
Phase:
NA
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 caregiv...
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, e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06093802
Start Date
January 1 2025
End Date
July 1 2029
Last Update
October 23 2023
Active Locations (1)
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1
Regional Hospital Gødstrup
Herning, Region of Central Jutland, Denmark, 7400