Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00233194
Eligibility Criteria:
Inclusion Criteria:
* Assent of child (if over the age of 9 or younger but able to understand the nature of the study)
* At least one parent or guardian must sign an informed consent
* Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason
* Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan
Exclusion Criteria:
* Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests
* Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines)
* Current treatment by a physician or past surgical treatment for SDB
* A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy)
* Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date
* Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study)
* Prior enrollment of a sibling in the study
* Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period
Additional exclusion criteria for healthy volunteers include:
* Any history of adenoidectomy or tonsillectomy
* Plans for either procedure in the future
* History of habitual snoring
* History of large (uninfected) tonsils
* History of recurrent throat infection that might be grounds for adenotonsillectomy (three episodes in each of 3 years, five episodes in each of 2 years, or seven episodes in one year)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT00233194
Study Brief:
Protocol Section:
NCT00233194