Sleep Disorders Trial, Recruiting NCT06609694 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06609694
Recruiting Not Applicable

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 aged 5 to 17 years, with or without Down Syndrome, may be considered for this trial.
  • Children who have been diagnosed with obstructive sleep apnea (a condition where breathing is repeatedly blocked during sleep) with a severity score between 5 and 40 breathing disruptions per hour may be eligible.
  • Children whose blood oxygen levels do not drop below 88% for 5 minutes or more, and do not drop as low as 60% at any point during sleep, may meet this criterion.

Who may not be able to join:

  • Children who are currently using a CPAP machine (a device that keeps airways open during sleep) and are using it consistently — more than 4 hours per night on more than 70% of nights — may not be eligible.
  • Children whose blood oxygen level falls below 90% while awake and at rest may not be eligible.
  • Children who are already using supplemental oxygen regularly, during the day or night, may not be eligible.
  • Children who are unable to complete an overnight sleep study (a test that monitors breathing and other body functions during sleep) may not be eligible.
  • Children who are already enrolled in, or planning to join, another research study that could interfere with this trial may not be eligible.

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 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Raouf Amin, MD, Children's Hospital Medical Center, Cincinnati

Phone: 513-636-4944

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
9 January 2023
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour

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: 12 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