The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
This trial is active, not recruiting.
|Condition||pediatric obstructive sleep apnea|
|Treatment||psychomotor vigilance testing|
|Sponsor||University of Arkansas|
|Collaborator||Arkansas Children's Hospital Research Institute|
|Start date||May 2010|
|End date||December 2016|
|Trial size||110 participants|
|Trial identifier||NCT01276860, 112316|
Obstructive sleep apnea results in decreased attentiveness and response times in patients. The objective of this study is to quantify these consequences in pediatric OSA patients using an already established tool for examining the results of sleep deprivation and fragmentation: psychomotor vigilance testing. PVT has been used in children, but has not been studied in pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and monitor treatment outcomes in these patients.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
OSA Subject PVT Sessions
time frame: 10-20 minutes each session, 3 sessions total
Control Subject PVT Session
time frame: 10-20 minute session, 1 session
Male or female participants from 6 years up to 18 years old.
Inclusion Criteria: - Healthy pediatric patients ages 6-18 years old - with symptoms of OSA (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches) - with physical exam findings consistent with adenotonsillar hypertrophy - those identified as good candidates for adenotonsillectomy - who are to undergo a polysomnogram as part of their preoperative work-up Exclusion Criteria: - History of attention deficit disorder, developmental delay, or mental retardation - Children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants) - Children previously treated for OSA (surgically or medically) - Children with significant comorbidities including other sleep-related disorders
|Official title||The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea|
|Principal investigator||Gresham T Richter, MD|
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