Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
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Purpose
Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children |
- Neurobehavioral improvement after AT [ Time Frame: Assessments at 4 and 10 months after AT ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
Other Names:
|
|
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
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 5 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children ages 5-12 years old,
- Scheduled for an adenotonsillectomy for treatment of sleep apnea,
- Child must provide assent, and
- Parent or legal guardian must be able to speak and read English, and agree to the study.
Exclusion Criteria:
- No siblings of children already enrolled in the study,
- Children who expect to have another surgery (in addition to AT) during the period of participation in this study,
- Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or
Certain medications that affect sleepiness or alertness, for example:
- Stimulants (such as Ritalin, Adderall, or Concerta),
- Sleep aides (such as Melatonin, Ambien, or Ativan), or
- Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian).
Contacts and Locations| Contact: Deborah L Ruzicka, PhD | (734) 936-9115 | druzicka@umich.edu |
| Contact: Ronald D Chervin, MD, MS | (734) 647-9064 | chervin@umich.edu |
| United States, Michigan | |
| University of Michigan Health System | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Deborah L Ruzicka, PhD 734-936-9115 druzicka@umich.edu | |
| Sub-Investigator: Susan L Garetz, MD, MS | |
| Sub-Investigator: Bruno J Giordani, PhD | |
| Sub-Investigator: Elise K Hodges, PhD | |
| Sub-Investigator: Timothy F Hoban, MD | |
| Sub-Investigator: Dawn Dore-Stites, PhD | |
| Sub-Investigator: Joseph W Burns, PhD | |
| Sub-Investigator: Deborah L Ruzicka, PhD | |
| Principal Investigator: | Ronald D. Chervin, MD, MS | University of Michigan |
More Information
No publications provided
| Responsible Party: | Ronald D. Chervin, M.D., M.S., Professor of Neurology, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01554527 History of Changes |
| Other Study ID Numbers: | F029661-00, 1R01HL105999-01A1 |
| Study First Received: | March 1, 2012 |
| Last Updated: | March 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Michigan:
|
polysomnography child continuous positive airway pressure tonsillectomy |
neuropsychological tests cognition sleepiness behavior |
Additional relevant MeSH terms:
|
Apnea Mental Disorders Child Behavior Disorders Disorders of Excessive Somnolence Sleep Apnea Syndromes Attention Deficit Disorder with Hyperactivity Hyperkinesis Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Mental Disorders Diagnosed in Childhood Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Dyskinesias Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 16, 2013