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Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

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ClinicalTrials.gov Identifier: NCT01554527
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Michigan Technological University
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan

March 1, 2012
March 15, 2012
October 26, 2018
January 14, 2019
January 14, 2019
March 2012
October 29, 2017   (Final data collection date for primary outcome measure)
Change in Behavioral Index After 6 Months of CPAP or No-CPAP [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
The sum of the T-scores of The Conners' Parent Rating Scales (CPRS-R:L, ADHD index) and the Child Behavior Checklist (CBCL, Attention Deficit/Hyperactivity Problems) are used to construct the primary study outcome measure Behavioral Index. Behavioral index is a T score (adjusted for age and gender) with a range of "<10" to ">90" - where higher scores mean worse behavior and lower scores mean better behavior, so a negative change score represents an improvement in behavior. T-scores with a mean of 50 and SD of 10 are computed.
Neurobehavioral improvement after AT [ Time Frame: Assessments at 4 and 10 months after AT ]
Parent ratings of behavior, with corroborative assessment from teachers, to determine potential benefits of CPAP use by children after AT
Complete list of historical versions of study NCT01554527 on ClinicalTrials.gov Archive Site
  • Change in Cognition as Shown by NIH Toolbox Composite Score [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
    Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40 and Maximum value 160. Higher scores are better
  • Change in Sleepiness as Measured by Epworth Sleepiness Scale [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
    Epworth Sleepiness Scale scores range from 0 to 24 where higher scores mean greater sleepiness.
  • Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT) [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
    Multiple Sleep Latency Test (MSLT) is an objective measure of sleepiness determined by measure of brain waves and other physiological signals over a 30 minute period. This is measured for five 30 minute periods across the day and average latency to sleep for each participant across those times were used to calculate the mean sleep latency. The score is measured in how quickly one would fall asleep, measured in minutes, so a negative number of minutes in the change score means that participants fell asleep more quickly than previously.
  • Change in Quality of Life as Measured by Peds QL [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
    Peds-QL is a quality of life symptom measurement with a score range of 0 to 100. Higher scores are better quality of life
  • CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently. [ Time Frame: Starting at 4 months after AT and continuing through 10 months after AT ]
    CPAP adherence data will be downloaded from CPAP machines. It is defined for this study as using the CPAP machine for at least an average of 4 hours per night during the last 60 days of the assignment.
  • Improvement in cognition after AT [ Time Frame: Testing at 4 and 10 months after AT ]
    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 ]
    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 ]
    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 ]
    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.
  • Change in Cognition as Measured by Fluid Cognition Scores [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
    Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40, Maximum value 160. Higher scores are better
  • Change in Cognition After AT as Shown by Academic Achievement [ Time Frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP ]
    Academic achievement mean score is a standardized score with a mean of 100 and SD 15. Minimum value 40 and Maximum value 160. Higher scores are better
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 Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Airway 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. For analysis purposes those children who were non-adherent (CPAP use <4 hours per night) vs. adherent (CPAP use at least 4 hours per night) will be analyzed separately.
    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.
 
Completed
120
Same as current
October 29, 2017
October 29, 2017   (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).
Sexes Eligible for Study: All
5 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01554527
F029661-00
1R01HL105999-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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
January 2019

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