Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
Recruiting
Phase 4
Interventional Study
Obstructive Sleep Apnea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 18
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 120 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Other
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About This Trial
To create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea (OSA). The first line of treatment for children with OSA is to remove their tonsils and adenoids; however, these surgeries do not always cure the patient. Another treatment, continuous positive airway pressure (CPAP) is only tolerated by 50% of children. Therefore, many childre…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or Female
* Subjects between the ages of 5 to 18 only for Aim 1 and xenon use
* Subjects 3-18 years of age for Aims 2 and 3
* Subjects with persistent moderate or severe OSA after adenotonsillectomy. - -- Persistent moderate or severe OSA will be defined as an oAHI \> 5 p…
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