Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)

Positive airway pressure (PAP) therapy has been shown to be an effective treatment which can
improve neurocognitive performance and sleep patterns in adults with obstructive sleep apnea
(OSA). However, the effect of PAP therapy on neurocognitive, behavioral and sleep patterns
in school-aged children with OSA is not well known. The goal of this innovative study is to
conduct a randomized, double-blind, placebo controlled, trial which will determine the
effects of PAP therapy on neurocognitive and behavioral patterns and sleep architecture in
children with OSA. A battery of neurocognitive tests and parent behavioral rating
assessments will be given to school-aged children with OSA before, after 3 months and again
after 6 months of treatment with PAP therapy only; or 3 months of PAP placebo use followed
by 3 months of PAP therapy. Full polysomnography and PAP titration sleep studies will be
performed following a night of adaptation sleep in a sleep laboratory at all three time
points. Compliance to PAP therapy will be monitored on a daily basis with a remote
internet-linked communicator that is attached to the participant's PAP pressure generator.
The hypothesis of this ground-breaking project is that 3 months of continuous compliance to
a regimen of PAP therapy will result in significant improvement in neurocognitive and
behavioral patterns and that sleep architecture will be positively changed to become more
reflective of normative values for school-aged children. The results of this innovative and
ground-breaking study will have far-reaching effects for sleep clinicians and other health
care providers in support of the continued use of PAP therapy as a treatment for OSA and to
inform the health-care community about the efficacy of PAP therapy on neurocognition and
behavior patterns in school-aged children with OSA.

Inclusion Criteria:

1. Age between 6.0 and 11.9 years

2. Nocturnal PSG (polysomnography) shows an apnea/hypopnea index of at least 1.5-10
events on average per hour of sleep and an apnea index of less than 1 per hour (mild
to moderate OSA group), or, PSG shows an apnea index of 1 or greater PLUS an
apnea/hypopnea index of 10.0 or greater (severe OSA group).

3. English is spoken as the child's primary language.

4. Willingness to complete study protocol if randomized into the placebo treatment
group.

Exclusion Criteria:

1. The presence of any other diagnosable sleep disorder other than OSA.

2. Previous use of PAP therapy for sleep disordered breathing at any time in the
patient's history

3. Presence of health problems likely to interfere with neurocognitive test result
interpretation, such as previously diagnosed psychiatric illness (i.e.,
attention-deficit hyperactivity disorder, depression, psychoses) or medical genetic
syndromes (i.e., Prader-Willi syndrome, Fragile X).

4. Presence of a chronic neurological disorder, chronic renal failure, diabetes,
rheumatoid arthritis, or another chronic inflammatory condition. -