NCT05303987 Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
| NCT ID | NCT05303987 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Erin Kirkham |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-10-05 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2022-10-05 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. A second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.
Eligibility Criteria
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
Contact & Investigator
Erin Kirkham, MD MPH
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05303987 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 11 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05303987 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05303987 currently recruiting?
Yes, NCT05303987 is actively recruiting participants. Contact the research team at nbrittan@med.umich.edu for enrollment information.
Where is the NCT05303987 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05303987 clinical trial?
NCT05303987 is sponsored by Erin Kirkham. The principal investigator is Erin Kirkham, MD MPH at University of Michigan. The trial plans to enroll 90 participants.