Brain Changes in Pediatric OSA
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|ClinicalTrials.gov Identifier: NCT05368077|
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : June 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obstructive Sleep Apnea||Procedure: Adenotonsillectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Brain Changes in Pediatric Obstructive Sleep Apnea|
|Actual Study Start Date :||May 14, 2022|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: 35 Pediatric Obstructive Sleep Apnea
The investigators will also determine whether brain tissue changes, reduced CBF, and altered neural responses to cognitive challenge reverse, and cognition and mood signs improve after standard surgical procedure "adenotonsillectomy" for breathing condition at 6 months in pediatric OSA.
Adenotonsillectomy is a standard surgical procedure for pediatric OSA treatment, which involves removal of hypertrophied tonsils and adenoids.
- Brain tissue changes between baseline and after adenotonsillectomy. [ Time Frame: 6 months ]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.
- Regional brain cerebral blood flow changes between baseline and after adenotonsillectomy. [ Time Frame: 6 months ]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.
- Neural response changes before and after adenotonsillectomy. [ Time Frame: 6 months ]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.
- Cognitive symptoms examination after adenotonsillectomy surgery. [ Time Frame: 6 months ]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).
- Cognition assessment after adenotonsillectomy in pediatric obstructive sleep apnea patients. [ Time Frame: 6 months ]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).
- Mood changes after adenotonsillectomy surgery. [ Time Frame: 6 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368077
|Contact: Rajesh Kumar, PhDemail@example.com|
|Contact: Bhaswati Roy, PhDfirstname.lastname@example.org|