Status:
COMPLETED
Identification of Sleep-Disordered Breathing in Children
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep
Sleep Apnea Syndromes
Eligibility:
All Genders
3-12 years
Brief Summary
The purpose of this research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these ...
Detailed Description
BACKGROUND: Sleep-disordered breathing (SDB) affects at least 1 to 3 percent of children. Associated morbidity can include inattentive and hyperactive behavior, disruptive behavior disorders, cogniti...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00233194
Start Date
January 1 2005
End Date
July 1 2011
Last Update
December 6 2016
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-0845