Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

This study is currently recruiting participants.
Verified May 2013 by University of Michigan
Sponsor:
Collaborators:
Michigan Technological University
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan
ClinicalTrials.gov Identifier:
NCT01554527
First received: March 1, 2012
Last updated: May 16, 2013
Last verified: May 2013

March 1, 2012
May 16, 2013
March 2012
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01554527 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Sleep Apnea Syndromes
  • Child Behavior Disorders
  • Attention Deficit Disorder With Hyperactivity
  • Disorders of Excessive Somnolence
  • Procedure: CPAP treatment
    6 months of treatment with PAP (CPAP or BPAP)
    Other Names:
    • Continuous positive airway pressure device (CPAP)
    • Bi-level positive airway pressure device (BPAP)
    • Positive Ariway Pressure device (PAP)
  • Other: No CPAP treatment
    Children randomized to the comparison group will receive routine care
    Other Names:
    • Comparison group
    • Control group
  • 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.
    Intervention: Procedure: CPAP treatment
  • 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.
    Intervention: Other: No CPAP treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
December 2015   (final data collection date for primary outcome measure)

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).
Both
5 Years to 12 Years
No
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
 
NCT01554527
F029661-00, 1R01HL105999-01A1
Yes
Ronald D. Chervin, M.D., M.S., University of Michigan
University of Michigan
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Michigan Technological University
Principal Investigator: Ronald D. Chervin, MD, MS University of Michigan
University of Michigan
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP