Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

Completed · Not applicable

Conditions studied: Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Child Behavior Disorders, Attention Deficit Disorder With Hyperactivity, Disorders of Excessive Somnolence

In brief

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.

Key facts

Study ID

NCT01554527

Run by

University of Michigan

People needed

120

Starts

2012-03-01

Expected to finish

2017-10-29

Last updated by the study team

2019-01-14

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children ages 5-12 years old,
• Scheduled for an adenotonsillectomy for treatment of sleep apnea,
• Child must provide assent, and
• Parent or legal guardian must be able to speak and read English, and agree to the study.

You may not qualify if…

• No siblings of children already enrolled in the study,
• Children who expect to have another surgery (in addition to AT) during the period of participation in this study,
• 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
• 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).

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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