Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
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|ClinicalTrials.gov Identifier: NCT01554527|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Sleep Apnea Syndromes Child Behavior Disorders Attention Deficit Disorder With Hyperactivity Disorders of Excessive Somnolence||Procedure: CPAP treatment Other: No CPAP treatment||Not Applicable|
Obstructive sleep-disordered breathing (SDB) affects at least 2-3% of children and may have substantial adverse impact on behavior and cognition. Adenotonsillectomy (AT), the second most common surgical procedure in children, is now performed more often for suspected SDB than for any other indication. However, recent studies among an increasingly obese population now show something alarming: many if not most children still have SDB after AT, and many still suffer from residual neurobehavioral morbidity. Furthermore, the investigators' ongoing, 12-year, NIH-funded research has shown that standard preoperative polysomnographic measures of SDB do not consistently predict post-AT improvement in behavior and cognition. This may arise in part because many children after AT still have SDB, and because linear relationships between standard SDB measures and neurobehavioral morbidity may not exist. Even at subtle levels, SDB may promote significant neurobehavioral morbidity. Some have suggested that polysomnography may be more important after AT than before AT. However, in practice few children receive polysomnography before AT, and even fewer after AT, when continuous positive airway pressure (CPAP) could still provide definitive relief from SDB. Preliminary data from our group suggest that CPAP after AT is well-tolerated by most children and may provide significant benefit. However, virtually no published evidence exists to address critical clinical questions: which children benefit most from CPAP after AT; what role can clinical symptoms or polysomnography play in that determination; and what neurobehavioral gains are achieved by CPAP after AT?
The investigators therefore will undertake a highly practical, clinical study with two main goals: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with CPAP after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment. This research will use reversible SDB-related neurobehavioral morbidity as the criteria by which to judge the utility of clinical symptoms and polysomnography in identification of candidates for CPAP after AT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||October 2017|
Experimental: CPAP treatment
Children randomized to this arm will receive 6 months of CPAP (or BPAP) treatment, beginning at approximately 4 months after AT, in addition to standard of care.
Procedure: CPAP treatment
6 months of treatment with PAP (CPAP or BPAP)
No CPAP treatment
Children randomized to this comparison arm will not be treated with CPAP or BPAP, but will be followed for approximately 10 months after AT while receiving standard of care.
Other: No CPAP treatment
Children randomized to the comparison group will receive routine care
- Neurobehavioral improvement after AT [ Time Frame: Assessments at 4 and 10 months after AT ]Parent ratings of behavior, with corroborative assessment from teachers, to determine potential benefits of CPAP use by children after AT
- Improvement in cognition after AT [ Time Frame: Testing at 4 and 10 months after AT ]Neuropsychological testing to characterize cognitive functioning after AT and possible benefits associated with 6 months of CPAP use after AT
- Improvement in sleepiness and other sleep apnea symptoms after AT [ Time Frame: Assessed at 4 and 10 months after AT ]Questionnaires to assess possible improvements in sleepiness, sleep or behavior complaints, and quality of life associated with CPAP use after AT
- Residual SDB, associated symptoms, and associated neurobehavioral problems after AT [ Time Frame: Testing at 4 months after AT ]Laboratory-based sleep studies (nocturnal polysomnograms and multiple sleep latency tests) to test for residual sleep apnea and daytime sleepiness after surgery; and behavioral, cognitive, and subjective sleepiness assessments. Examples of sleep measures to be included are: rates of apneic events, oxygen desaturation, arousals, sleep stages, esophageal pressures, and respiratory cycle-related EEG changes [RCREC]
- CPAP Adherence and Safety Monitoring [ Time Frame: Starting at 4 months after AT and continuing through 10 months after AT ]CPAP adherence data will be downloaded from CPAP machines. Data on any adverse events, intercurrent events, or unanticipated problems will provide safety data on CPAP use after AT, or on morbidity in children not given CPAP after AT.
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): NCT01554527
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ronald D. Chervin, MD, MS||University of Michigan|