Identification of Sleep-Disordered Breathing in Children
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|ClinicalTrials.gov Identifier: NCT00233194|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment|
|Sleep Sleep Apnea Syndromes Sleep Disordered Breathing||Procedure: Observational follow-up study of adenotonsillectomy|
Sleep-disordered breathing (SDB) affects at least 1 to 3 percent of children. Associated morbidity can include inattentive and hyperactive behavior, disruptive behavior disorders, cognitive deficits, and excessive daytime sleepiness. Sleep specialists recommend that children undergo polysomnography to confirm SDB, especially before undergoing treatment, which often involves an adenotonsillectomy. Unfortunately, such testing is rarely performed either before or after surgery. Available data suggest that a clinical diagnosis of SDB does not predict polysomnographic results reliably. However, the extent to which polysomnographic results predict morbidity, and especially treatable morbidity, is not well known. The main goal of the proposed research, therefore, is to study and improve methods for identification of childhood SDB that carries reversible morbidity.
Researchers will examine the utility of polysomnography in a group of children scheduled to undergo adenotonsillectomy for clinical indications, and a group of matched control subjects. Initial evaluations, before surgery in the first group, will be compared to results of identical evaluations 6 months later in this controlled nonrandomized trial. Outcomes will be provided by well-validated assessments of behavior, psychiatric status, cognition, and sleepiness. Explanatory variables will include standard clinical and polysomnographic information, and data from two newer techniques. The first, nasal pressure monitoring, shows increased sensitivity for events that characterize SDB, but few results and no outcome data have been reported from use of this method in children. The second is an innovative signal processing algorithm developed by the investigators to show that cortical electroencephalogram (EEG) activity changes in synchrony with non-apneic respiratory cycles in children with SDB. Preliminary data suggest that the magnitude of respiratory cycle-related EEG changes (RCREC) varies with SDB severity, diminishes after SDB treatment, and improves prediction of neurobehavioral outcomes. The specific aims of the proposed research are to show that 1) nasal pressure monitoring, in comparison to standard measures of airflow, improves prediction of neurobehavioral response to adenotonsillectomy; 2) RCREC, in comparison to standard visually-scored EEG-based arousals, do likewise; 3) polysomnographic SDB measures, including nasal pressure monitoring and RCREC, add useful information to that derived from office-based assessments; and 4) polysomnography after adenotonsillectomy can identify clinically relevant residual SDB in some children.
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Identification of Sleep-Disordered Breathing in Children|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||July 2011|
Children scheduled for adenotonsillectomy and healthy subjects, for comparison, not scheduled for such surgery.
Procedure: Observational follow-up study of adenotonsillectomy
Studies of sleep, behavior, cognition, and daytime sleepiness
Other Name: Adenotonsillectomy vs. non-surgical subjects
- Overall behavior [ Time Frame: Measured for approximately 6 months ]
- Psychiatric status [ Time Frame: Measured for approximately 6 months ]
- Cognition [ Time Frame: Measured for approximately 6 months ]
- Sleepiness (measured immediately before surgery and 6 months after surgery) [ Time Frame: Measured for approximately 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233194
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109-0845|
|Principal Investigator:||Ronald D Chervin, MD, MS||University of Michigan|