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NCT05368077 · ClinicalTrials.gov registry record · NA
Brain Changes in Pediatric OSA
A NA study of Pediatric Obstructive Sleep Apnea, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT05368077: Completed NA study of Pediatric Obstructive Sleep Apnea, sponsored by University of California, Los Angeles.
NCT05368077 is a NA study of Pediatric Obstructive Sleep Apnea that has completed, run by University of California, Los Angeles. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05368077, a NA study of Pediatric Obstructive Sleep Apnea, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study 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 Outcome
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 in
Conditions Studied
Interventions
- PROCEDURE Adenotonsillectomy
Study Locations (1)
California
- UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2022-05-14 |
| Est. Completion | 2024-07-31 |
| Phase | NA |
What the finished NCT05368077 record still lists
NCT05368077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Pediatric Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Adenotonsillectomy is the first listed.
NCT05368077 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05368077 about?
NCT05368077 is a clinical study titled "Brain Changes in Pediatric OSA". 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...
What is the current status of trial NCT05368077?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2022-05-14. Estimated completion is 2024-07-31.
What conditions does trial NCT05368077 study?
This clinical trial studies the following conditions: Pediatric Obstructive Sleep Apnea.
What interventions are being tested in trial NCT05368077?
The interventions under investigation include: Adenotonsillectomy (PROCEDURE).
Who is sponsoring clinical trial NCT05368077?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05368077 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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