CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Adenotonsillectomyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05368077
NCT05368077N/ACompleted

Brain Changes in Pediatric Obstructive Sleep Apnea

University of California, Los Angeles·interventional·Posted May 10, 2022·Updated Nov 29, 2024

In Brief

A clinical study evaluating Adenotonsillectomy for Pediatric Obstructive Sleep Apnea. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 10, 2022
Enrollment StartMay 14, 2022
Primary CompletionJul 31, 2023
Study CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.1 years ago

Interventions

Adenotonsillectomyprocedure

Adenotonsillectomy is a standard surgical procedure for pediatric OSA treatment, which involves removal of hypertrophied tonsils and adenoids.