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| Descriptive Information Fields | |||||
| Brief Title † | Identification of Sleep-Disordered Breathing in Children | ||||
| Official Title † | Identification of Sleep-Disordered Breathing in Children | ||||
| 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 sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed. |
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| 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, 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. DESIGN NARRATIVE: 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Cohort, Prospective | ||||
| Primary Outcome Measure † | Overall behavior [ Time Frame: Measured for approximately 6 months ] [ Designated as safety issue: No ] Psychiatric status [ Time Frame: Measured for approximately 6 months ] [ Designated as safety issue: No ] Cognition [ Time Frame: Measured for approximately 6 months ] [ Designated as safety issue: No ] Sleepiness (measured immediately before surgery and 6 months after surgery) [ Time Frame: Measured for approximately 6 months ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Sleep Sleep Apnea Syndromes Sleep Disordered Breathing |
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| Intervention † | Procedure: Observational follow-up study of adenotonsillectomy | ||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 150 | ||||
| Start Date † | January 2005 | ||||
| Completion Date | July 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for healthy volunteers include:
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| Gender | Both | ||||
| Ages | 3 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00233194 | ||||
| Organization ID | 324 | ||||
| Secondary IDs †† | R01 HL080941 | ||||
| Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | October 3, 2005 | ||||
| Last Updated Date | August 5, 2008 | ||||