Phase 2 Sleep Disorders Trial, Recruiting NCT05303987 Sponsor: Erin Kirkham Condition: Sleep Disorders
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Phase 2 Sleep Disorders Trial, Recruiting

NCT05303987
Recruiting Phase 2

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:

  • The child has been diagnosed with obstructive sleep apnea (a condition where breathing repeatedly stops during sleep), confirmed by an overnight sleep study done in an accredited sleep laboratory within the past 12 months.
  • A qualified ear, nose, and throat (ENT) specialist has assessed the child and determined that surgery to remove the tonsils and adenoids is an appropriate treatment option.
  • The child's ENT surgeon has determined that a sleep endoscopy (a procedure to look at the airway while the child is asleep) before surgery would be beneficial, due to one or more risk factors such as: obesity (above the 95th percentile for body mass index for their age), severe sleep apnea, a mismatch between what the doctor sees during a physical exam and the severity of symptoms, African American race, or being 7 years of age or older.
  • The child is between 3 and 11 years of age at the time of consent.
  • A parent or guardian is able to understand and sign a written consent form.
  • A parent or guardian is able to read, understand, and speak English or Spanish, and is willing to complete questionnaires.

Who may not be able to join:

  • The child has previously had their tonsils and adenoids removed, or has had other upper airway surgery, including a tracheostomy — with the exception of adenoid-only removal if it took place more than 18 months before joining the trial.
  • The child has a significant medical condition that could be made worse by the study treatment, could put the child at unusual risk, or could affect the reliability of the study results.
  • The child has had an allergic reaction to, or a medical reason not to receive, any of the following anaesthetic medications: propofol, dexmedetomidine, ketamine, or sevoflurane.
  • The child has an allergy to eggs, egg products, soybeans, or soybean products.
  • There is a medical reason why the child cannot safely receive general anaesthesia.

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 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Erin Kirkham, MD MPH, University of Michigan

Phone: 734-232-1740

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 2
Sponsor
Erin Kirkham
Registry
ClinicalTrials.gov
Start date
5 October 2022
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean obstruction score at the tongue base

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: 27 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