Pediatric Obstructive Sleep Apnea Clinical Trial
Official title:
Brain Changes in Pediatric Obstructive Sleep Apnea
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.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | July 31, 2024 |
| Est. primary completion date | April 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | UCLA | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Los Angeles |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brain tissue changes between baseline and after adenotonsillectomy. | The investigators will examine whether brain tissue changes reverse after adenotonsillectomy in pediatric obstructive sleep apnea subjects. The investigators will use diffusion tensor imaging based mean diffusivity and diffusion kurtosis imaging based mean kurtosis measures to examine brain tissue changes; both procedures examine brain tissue integrity with mean diffusivity showing reduced and mean kurtosis indicating increased values in acute tissue changes, and with mean diffusivity showing increased and mean kurtosis showing reduced values in chronic tissue changes. | 6 months | |
| Primary | Regional brain cerebral blood flow changes between baseline and after adenotonsillectomy. | Using arterial spin labeling magnetic resonance imaging, the investigators will assess if regional cerebral blood flow improves after standard obstructive sleep apnea surgery in pediatric subjects. The cerebral blood flow values reduce with hypo-perfusion and increase with hyper-perfusion. | 6 months | |
| Primary | Neural response changes before and after adenotonsillectomy. | Using functional magnetic resonance imaging, the investigators will examine whether neural responses in brain cognitive control sites to arithmetic cognitive challenge will improve after adenotonsillectomy compared to baseline in pediatric obstructive sleep apnea subjects. | 6 months | |
| Primary | Cognitive symptoms examination after adenotonsillectomy surgery. | The investigators will examine cognitive symptom changes after adenotonsillectomy in pediatric obstructive sleep apnea subjects. The investigators will use the Differential Ability Scale II for cognition evaluation. The Differential Ability Scale II scores range from 30-170, with reduced values indicating impaired cognition (General Conceptual Ability score <90, abnormal; General Conceptual Ability score > 90-170, normal). | 6 months | |
| Primary | Cognition assessment after adenotonsillectomy in pediatric obstructive sleep apnea patients. | The investigators will assess cognition changes after adenotonsillectomy in pediatric obstructive sleep apnea subjects. The investigators will use the NEuroPSYchological Assessment II for cognition examination. The NEuroPSYchological Assessment II scores will be lower with impaired cognition (Scaled score <8, abnormal; Scaled score 8-19, normal). | 6 months | |
| Primary | Mood changes after adenotonsillectomy surgery. | The investigators will examine mood changes after adenotonsillectomy in pediatric obstructive sleep apnea subjects using the Child Behavior Checklist. The Child Behavior Checklist scores will be higher with mood symptoms in pediatric obstructive sleep apnea compared to control children (t-scores, 65-69 borderline; >70 clinical). | 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01276860 -
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
|
N/A | |
| Terminated |
NCT03821831 -
Treating Children With Obstructive Sleep Apnea After Surgery Failure
|
||
| Recruiting |
NCT05052216 -
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
|