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Brain Changes in Pediatric OSA

About

Brief Summary

Obstructive sleep apnea (OSA) is highly prevalent in children and is often caused by overgrowth of the child's adenoids and/or tonsils. Consequently, adenotonsillectomy (removal of the tonsils and adenoids) is the most common treatment of OSA in children, although just the tonsils or adenoids may be removed depending on the case. As well, OSA in children is often associated with cognitive dysfunction and mood issues, suggesting brain changes due to the condition. However, the link between brain changes, cognitive and moods issues, and OSA in children has not been thoroughly explored. Therefore, this study aims to examine brain changes, cognition and mood in pediatric OSA subjects compared to controls as well as before and after removal of the adenoids and/or tonsils. This study hopes to enroll 70 subjects, ages 7-12 years, 35 healthy controls and 35 subjects diagnosed with OSA and scheduled for an adenoidectomy and/or tonsillectomy. Control subjects will schedule one visit to UCLA and OSA subjects will schedule two. Upon the first visit, all subjects will undergo cognitive, mood and sleep questionnaires and MRI scanning. That will be the duration of the controls' participation in the study; however, OSA subjects will return 6 months later (after their adenoidectomy and/ or tonsillectomy) to repeat the same procedures. Sleep quality, mood, cognition and brain images will be compared between OSA and controls and between OSA subjects before surgery and after surgery.

Primary Purpose
Basic Science
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
7 Years
Maximum Age
12 Years

Inclusion Criteria:

OSA

  • Pediatric OSA subjects will be in the age range 7-12 years (upper and lower age limit will be chosen to avoid developmental-related brain changes and potential requirement of anesthesia for brain MRI)
  • Have a diagnosis of at least moderate OSA (AHI>5 events/hour) via overnight polysomnography at a sleep laboratory
  • Without obesity (≥95th percentile BMI for age and sex) to avoid perioperative issues
  • No treatment for the breathing condition
  • Undergoing for adenotonsillectomy. Control subjects
  • Healthy children
  • Age-range from 7-12 years (within ±3 months)
  • Sex- and BMI-matched (±2 kg/m2) to pediatric OSA
  • No medications for brain disorders
  • Without any diagnosed neurological condition

Exclusion Criteria:

  • Previous history of diagnosed psychiatric diseases (depression and other brain disorders that may introduce brain injury)
  • Cystic fibrosis, concussion, and presence of space-occupying brain lesions
  • Metallic or electronic implants and other MRI-specific exclusion criteria

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Study Stats
Protocol No.
21-000408
Category
Anesthesiology & Perioperative Medicine
Principal Investigator
Rajesh Kumar
Contact
Bhaswati Roy
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05368077
For detailed technical eligibility, visit ClinicalTrials.gov.