Improving surgical outcomes for children with obstructive sleep apnea using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to develop a validated computational tool that predicts surgical outcomes for pediatric patients suffering from obstructive sleep apnea (OSA). The study focuses on children aged 3 to 18 who have persistent moderate or severe OSA after adenotonsillectomy and have either failed CPAP treatment or are opting for surgery. By utilizing computational fluid dynamics (CFD) simulations alongside real-time magnetic resonance imaging (MRI), the research seeks to compare various surgical options virtually, enhancing the decision-making process for individualized treatment. The goal is to improve the efficacy of surgical interventions aimed at alleviating airway obstruction in these patients.

Why it matters

Who can join: the full rules

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 per hour of sleep.
* Clinical indication or suspicion of upper-airway obstruction. Examples include but not limited to hypertrophy of the lingual tonsils, disproportionately large tongue, or micrognathia.
* Subjects who have failed a trial of CPAP.
* Subjects whose parents elect to pursue surgery without a trial of CPAP.
* Subjects who require a surgical procedure for OSA based on the clinical assessment of the surgeon (otolaryngologist or plastic surgeon).

Exclusion Criteria:

* Children adequately treated with CPAP.
* Children with braces/metal rods.
* Children who have a contraindication to sedative.
* Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Alister Bates, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Penny New, MS
• Email: Penny.New@cchmc.org
• Phone: (513) 636-9973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.