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NCT05368077
Brain Changes in Pediatric OSA
NA trial testing Adenotonsillectomy in Pediatric Obstructive Sleep Apnea in 56 participants. Completed in 31 July 2024.
31 July 2023
Quick facts
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 56 |
| Start date | 14 May 2022 |
| Primary completion | 31 July 2023 |
| Estimated completion | 31 July 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Adenotonsillectomy
Conditions studied
- Pediatric Obstructive Sleep Apnea — all drugs for Pediatric Obstructive Sleep Apnea →
Sponsor
University of California, Los Angeles
Who can join
Adults 7 to 12, any sex, with Pediatric Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05368077
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Adenotonsillectomy
Trials testing the same drug.
- NCT07527260 — Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR · NA · not yet recruiting
- NCT06258837 — Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils · NA · recruiting
- NCT05508971 — Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS) · NA · recruiting
- NCT06917768 — Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea · NA · completed
- NCT05154214 — Surgical Treatment of Children With OSA and Small Tonsils or Down Syndrome · completed
Other recruiting trials for Pediatric Obstructive Sleep Apnea
Currently open trials in the same condition.
- NCT06850220 — Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children · recruiting
- NCT05052216 — Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea · recruiting
Other University of California, Los Angeles trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05368077 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
- Last refreshed: 29 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05368077.
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