Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233194
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2005-10-03
Brief Title:
Identification of Sleep-Disordered Breathing in Children
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Identification of Sleep-Disordered Breathing in Children
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL080941 | NIH | None | httpsreporternihgovquickSearchR01HL080941 |