The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea (PVT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01276860
First received: January 12, 2011
Last updated: December 12, 2013
Last verified: December 2013

January 12, 2011
December 12, 2013
May 2010
December 2014   (final data collection date for primary outcome measure)
OSA Subject PVT Sessions [ Time Frame: 10-20 minutes each session, 3 sessions total ] [ Designated as safety issue: No ]
Subjects with obstructive sleep apnea will be asked to participate in 3 sessions. Your child will be asked to complete some noninvasive tests at each session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. The PVT testing will be done at the first clinic visit, then before any treatments, and finally after treatments have taken place.
Same as current
Complete list of historical versions of study NCT01276860 on ClinicalTrials.gov Archive Site
Control Subject PVT Session [ Time Frame: 10-20 minute session, 1 session ] [ Designated as safety issue: No ]
Subjects in the control group without clinical signs and symptoms of sleep apnea will only undergo PVT for one session. Your child will be asked to complete some noninvasive tests at this session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete.
Same as current
Not Provided
Not Provided
 
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pediatric Obstructive Sleep Apnea
Device: Psychomotor Vigilance Testing
The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01276860
112316
Yes
University of Arkansas
University of Arkansas
Arkansas Children's Hospital Research Institute
Principal Investigator: Gresham T Richter, MD UAMS, ACH
University of Arkansas
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP