Clinical trial NCT01554527: Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
Official title: Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Child Behavior Disorders
Attention Deficit Disorder With Hyperactivity
Disorders of Excessive Somnolence
Keywords: polysomnography
child
continuous positive airway pressure
tonsillectomy
neuropsychological tests
cognition
sleepiness
behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Michigan Technological University
First posted: 2012-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Behavioral Index After 6 Months of CPAP or No-CPAP
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Secondary outcomes:
measure: Change in Cognition as Shown by NIH Toolbox Composite Score
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
measure: Change in Sleepiness as Measured by Epworth Sleepiness Scale
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
measure: Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT)
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
measure: Change in Quality of Life as Measured by Peds QL
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
measure: CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently.
timeFrame: Starting at 4 months after AT and continuing through 10 months after AT
Other outcomes:
measure: Change in Cognition as Measured by Fluid Cognition Scores
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
measure: Change in Cognition After AT as Shown by Academic Achievement
timeFrame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ronald D. Chervin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: