| Conditions: |
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Sleep Apnea, Obstructive - Sleep Apnea Syndromes - Child Behavior Disorders - Attention Deficit Disorder With Hyperactivity - Disorders of Excessive Somnolence |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. Children ages 5-12 years old,
2. Scheduled for an adenotonsillectomy for treatment of sleep apnea,
3. Child must provide assent, and
4. Parent or legal guardian must be able to speak and read English, and agree to the
study.
Exclusion Criteria:
1. No siblings of children already enrolled in the study,
2. Children who expect to have another surgery (in addition to AT) during the period of
participation in this study,
3. 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
4. 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).
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| NCT ID: |
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NCT01554527 |
| Primary Contact: |
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Principal Investigator
Ronald D. Chervin, MD, MS
University of Michigan
Deborah L Ruzicka, PhD
Phone: (734) 936-9115
Email: druzicka@umich.edu
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| Backup Contact: |
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Email: chervin@umich.edu
Ronald D Chervin, MD, MS
Phone: (734) 647-9064
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| Location Contact: |
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Ann Arbor, Michigan 48109
United States
Deborah L Ruzicka, PhD
Phone: 734-936-9115
Email: druzicka@umich.edu
Site Status: Recruiting |