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New treatment option for Obstructive Sleep Apnea
Official title Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
ClinicalTrials.gov ID: NCT04991389
What this study is testing
What is 129-Xe?
129-Xe is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for obstructive sleep apnea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- Male or Female
- people between the ages of 5 to 18 only for Aim 1 and xenon use
- people 3-18 years of age for Aims 2 and 3
- people with persistent moderate or severe OSA after adenotonsillectomy. - -- Persistent moderate or severe OSA will be defined as an oAHI \> 5 per...
- Clinical indication or suspicion of upper-airway obstruction. Examples include but not limited to hypertrophy of the lingual tonsils...
You likely can't join if
- 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.
See the full eligibility criteria
- Male or Female
- people between the ages of 5 to 18 only for Aim 1 and xenon use
- people 3-18 years of age for Aims 2 and 3
- people 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.
- people who have failed a trial of CPAP.
- people whose parents elect to pursue surgery without a trial of CPAP.
- people who require a surgical procedure for OSA based on the clinical assessment of the surgeon (otolaryngologist or plastic surgeon).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.