Overview

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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
OSA Subject PVT Sessions
time frame: 10-20 minutes each session, 3 sessions total

Secondary Outcomes

Measure
Control Subject PVT Session
time frame: 10-20 minute session, 1 session

Eligibility Criteria

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

Additional Information

Official title The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Principal investigator Gresham T Richter, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Arkansas.