Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children



Status:Completed
Conditions:Insomnia Sleep Studies, Neurology, Psychiatric, Pulmonary
Therapuetic Areas:Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 12
Updated:1/16/2019
Start Date:March 2012
End Date:October 29, 2017

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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.

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).
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 734-647-9064
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