Comparing two anesthetics for sleep endoscopy in children with sleep apnea

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 study aims to compare the effects of two anesthetics, dexmedetomidine and propofol, on airway collapse during drug-induced sleep endoscopy in children diagnosed with obstructive sleep apnea (OSA). The research will assess whether the level of airway collapse observed during the procedure correlates with persistent OSA after adenotonsillectomy, a common surgical treatment for this condition. By evaluating these anesthetics, the study seeks to improve understanding of their impact on airway dynamics in pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.
2. Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.
3. Clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include:

   1. Obese (\>95th percentile of body mass index for age)
   2. Severe preoperative OSA (AHI ≥10 events/hour)
   3. Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;
   4. African American race
   5. Age ≥7 years old
4. Male or Female ages 3.00 - 11.99 years of age at the time of consent
5. Parent/guardian ability to understand and willingness to sign a written informed consent..
6. Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.

Exclusion Criteria:

1. Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \>18 months prior to recruitment.
2. Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results
3. History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane
4. Allergy to eggs, egg products, soybeans or soybean products.
5. Contraindication to receiving general anesthesia

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Erin Kirkham, MD MPH — University of Michigan
• Study coordinator: Brittany Nordhaus
• Email: nbrittan@med.umich.edu
• Phone: 734-232-1740

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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.