Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
Condition: Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Child Behavior Disorders; Attention Deficit Disorder With Hyperactivity; Disorders of Excessive Somnolence
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness; Attention Deficit Disorder with Hyperactivity; Mental Disorders; Child Behavior Disorders
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): CPAP treatment; No CPAP treatment
Intervention type(s): Procedure; Other
Intervention description(s): 6 months of treatment with PAP (CPAP or BPAP); Children randomized to the comparison group will receive routine care
Other intervention name(s): Continuous positive airway pressure device (CPAP); Bi-level positive airway pressure device (BPAP); Positive Airway Pressure device (PAP); Comparison group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polysomnography; child; continuous positive airway pressure; tonsillectomy; neuropsychological tests; cognition; sleepiness; behavior