Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Child Behavior Disorders
Attention Deficit Disorder With Hyperactivity
Disorders of Excessive Somnolence
Procedure: CPAP treatment
Other: No CPAP treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
Other: No CPAP treatment
Children randomized to the comparison group will receive routine care
Other Names:
  • Comparison group
  • Control group

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

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554527

Contacts
Contact: Deborah L Ruzicka, PhD (734) 936-9115 druzicka@umich.edu
Contact: Ronald D Chervin, MD, MS (734) 647-9064 chervin@umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Deborah L Ruzicka, PhD    734-936-9115    druzicka@umich.edu   
Sub-Investigator: Susan L Garetz, MD, MS         
Sub-Investigator: Bruno J Giordani, PhD         
Sub-Investigator: Elise K Hodges, PhD         
Sub-Investigator: Timothy F Hoban, MD         
Sub-Investigator: Dawn Dore-Stites, PhD         
Sub-Investigator: Joseph W Burns, PhD         
Sub-Investigator: Deborah L Ruzicka, PhD         
Sponsors and Collaborators
University of Michigan
Michigan Technological University
Investigators
Principal Investigator: Ronald D. Chervin, MD, MS University of Michigan
  More Information

No publications provided

Responsible Party: Ronald D. Chervin, M.D., M.S., Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT01554527     History of Changes
Other Study ID Numbers: F029661-00, 1R01HL105999-01A1
Study First Received: March 1, 2012
Last Updated: April 17, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
polysomnography
child
continuous positive airway pressure
tonsillectomy
neuropsychological tests
cognition
sleepiness
behavior

Additional relevant MeSH terms:
Apnea
Mental Disorders
Child Behavior Disorders
Disorders of Excessive Somnolence
Sleep Apnea Syndromes
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 27, 2014