Phase 4 Sleep Disorders Trial, Recruiting NCT04991389 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT04991389
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children and teenagers between the ages of 5 and 18 (for one part of the study involving xenon gas imaging), or between the ages of 3 and 18 (for other parts of the study)
  • Children who still have moderate or severe sleep apnea after having their tonsils and adenoids removed, defined as having more than 5 breathing pauses per hour during sleep
  • Children who show signs of an upper airway blockage, such as enlarged tongue tissue at the back of the throat, an unusually large tongue, or a smaller-than-typical jaw
  • Children for whom CPAP (a breathing machine used during sleep) has been tried but did not work well enough
  • Children whose parents have chosen to pursue surgery rather than trying CPAP
  • Children who a surgeon (ear, nose and throat specialist or plastic surgeon) has determined need surgery to treat their sleep apnea

Who may not be able to join:

  • Children whose sleep apnea is being successfully managed with CPAP
  • Children who have braces or metal rods in their body
  • Children who cannot safely receive sedation (calming or sleep medication)
  • Children who do not meet the standard safety requirements for having an MRI scan, as determined by the radiology department at the study site (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Alister Bates, PhD, Children's Hospital Medical Center, Cincinnati

Phone: (513) 636-9973

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
15 August 2019
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Predict the surgical option with the most successful outcome with patient-specific validation computational fluid dynamics (CFD) airflow simulations of respiratory upper airways of children with DS and OSA using inhaled Xenon gas phase-contrast MRI.; Measure changes in geometric analysis of airway, airway resistance, and pressure forces with surgical outcome as measured by changes in oAHI (obstructive apnea-hypopnea index)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov